guideline Specifications
guideline is a starting point for companies wishing to obtain eventual FDA/CE certification for a medical grade device knowing that the raw material itself is listed with the FDA and has already passed specific FDA testing.
guidel!ne
guidel!ne is sold as a raw material modified in form only into 3d printing line and most important, extruded in a manner that keeps contaminates out of the material during the cooling process, where contaminates and bacteria could be embedded in the soft extrusion. In addition, pH and ORP levels are monitored and adjusted to maintain acceptable levels.
guidel!ne is sold as a raw material modified in form only into 3d printing line and most important, extruded in a manner that keeps contaminates out of the material during the cooling process, where contaminates and bacteria could be embedded in the soft extrusion. In addition, pH and ORP levels are monitored and adjusted to maintain acceptable levels.
guidel!ne
Information provided to the user will be in sync with the FDA’s “Technical Considerations for Additive Manufactured Devices Draft Guidance for Industry and Food and Drug Administration Staff”. Section “C” “Material Controls”. While COA’s will be the responsibility of the end user, taulman3D will provide information to support such efforts.
guidel!ne meets the following:
ISO 11607-1: 2006
ISO 10993
USP Class VI
USP <661>
DMF (Drug Master File) number 16525
Print temperature = 245C to 252C
When 3D Printed, guidel!ne has a tensile strength of 6,850PSI.
Elongation is 5.9 and a modulus of 281,469PSI.
Heat distortion temp is 70C.
Softening temperature is 100C
guidel!ne is a clear PETG based polymer that prints at 250C. guidel!ne is very easy to print needing only a small amount of retraction. A key feature of guidel!ne is that one can easily print small hollow tubes without the issue of heat build-up deforming the tube.
To register your spool/s of guidel!ne, send an email to the address below and include your serial # in the subject line.
In the body, include any info you wish to provide as to your use of guidel!ne.
guidel!ne meets the following:
ISO 11607-1: 2006
ISO 10993
USP Class VI
USP <661>
DMF (Drug Master File) number 16525
Print temperature = 245C to 252C
When 3D Printed, guidel!ne has a tensile strength of 6,850PSI.
Elongation is 5.9 and a modulus of 281,469PSI.
Heat distortion temp is 70C.
Softening temperature is 100C
guidel!ne is a clear PETG based polymer that prints at 250C. guidel!ne is very easy to print needing only a small amount of retraction. A key feature of guidel!ne is that one can easily print small hollow tubes without the issue of heat build-up deforming the tube.
To register your spool/s of guidel!ne, send an email to the address below and include your serial # in the subject line.
In the body, include any info you wish to provide as to your use of guidel!ne.
guidel!ne is sold as a raw material modified in form only into 3d printing line and most important, extruded in a manner that keeps contaminates out of the material during the cooling process, where contaminates and bacteria could be embedded in the soft extrusion.
In addition, pH and ORP levels are monitored and adjusted to maintain acceptable levels.
In addition, pH and ORP levels are monitored and adjusted to maintain acceptable levels.
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Terms and Conditions of taulman3D.com
By using the taulman3D.com website, you agree to comply with and be bound by the following terms and conditions:
Contents of taulman3D.com is for your general information and use only and is subject to change without notice. Materials sold on this website should only be used by experienced individuals or under the supervision of experts. Use of the products sold on taulman3D.com is entirely at your own risk. To the fullest extent permissible by law, we hereby disclaim all responsibility, risk, liability, warranty invalidation, and damages arising out of any harm, loss, injury, or death resulting from the use or misuse of our materials or products. Materials, and information provided on or through taulman3D.com are provided "as is" without any warranties of any kind. It shall be your own responsibility to ensure that any materials or information made available through taulman3D.com meet your specific requirements and purpose. We expressly exclude liability for any inaccuracies or errors in the product descriptions presented on this website. Material spooled weight may vary slightly from advertised weight and material diameter sizes are nominal due to the extrusion process. We reserve the right to limit the order quantity and refuse service to any customer. You are responsible for paying any import duties and taxes on your order. You are responsible for contacting us to initiate any claim for damaged or lost shipments. You are responsible for any return or repeat shipping charges for packages returned to us due to an invalid or insufficient address. All use of taulman3D.com and its products shall be governed by and construed in accordance with the statutes and laws of the State of Missouri. Any action seeking legal or equitable relief arising out of or relating to the use of taulman3D.com will be subject to the jurisdiction and venue of the state and federal courts of St Louis, Missouri. taulman3D.com reserves the right to change, suspend, or discontinue any product or aspect on taulman3D.com at any time without notice.
By using the taulman3D.com website, you agree to comply with and be bound by the following terms and conditions:
Contents of taulman3D.com is for your general information and use only and is subject to change without notice. Materials sold on this website should only be used by experienced individuals or under the supervision of experts. Use of the products sold on taulman3D.com is entirely at your own risk. To the fullest extent permissible by law, we hereby disclaim all responsibility, risk, liability, warranty invalidation, and damages arising out of any harm, loss, injury, or death resulting from the use or misuse of our materials or products. Materials, and information provided on or through taulman3D.com are provided "as is" without any warranties of any kind. It shall be your own responsibility to ensure that any materials or information made available through taulman3D.com meet your specific requirements and purpose. We expressly exclude liability for any inaccuracies or errors in the product descriptions presented on this website. Material spooled weight may vary slightly from advertised weight and material diameter sizes are nominal due to the extrusion process. We reserve the right to limit the order quantity and refuse service to any customer. You are responsible for paying any import duties and taxes on your order. You are responsible for contacting us to initiate any claim for damaged or lost shipments. You are responsible for any return or repeat shipping charges for packages returned to us due to an invalid or insufficient address. All use of taulman3D.com and its products shall be governed by and construed in accordance with the statutes and laws of the State of Missouri. Any action seeking legal or equitable relief arising out of or relating to the use of taulman3D.com will be subject to the jurisdiction and venue of the state and federal courts of St Louis, Missouri. taulman3D.com reserves the right to change, suspend, or discontinue any product or aspect on taulman3D.com at any time without notice.