PuraKOTE YSSKTE
GUDID 10813954026777
Collagen Dental Dressing
COLLAGEN MATRIX, INC.
General oral wound dressing, animal-derived| Primary Device ID | 10813954026777 |
| NIH Device Record Key | eccd588e-2534-465a-a3c2-86f9ef93539c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PuraKOTE |
| Version Model Number | YSSKTE |
| Catalog Number | YSSKTE |
| Company DUNS | 176262442 |
| Company Name | COLLAGEN MATRIX, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | (877) 540-3258 |
| info@puragraft.com | |
| Phone | (877) 540-3258 |
| info@puragraft.com | |
| Phone | (877) 540-3258 |
| info@puragraft.com | |
| Phone | (877) 540-3258 |
| info@puragraft.com | |
| Phone | (877) 540-3258 |
| info@puragraft.com | |
| Phone | (877) 540-3258 |
| info@puragraft.com | |
| Phone | (877) 540-3258 |
| info@puragraft.com | |
| Phone | (877) 540-3258 |
| info@puragraft.com | |
| Phone | (877) 540-3258 |
| info@puragraft.com |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00813954026770 [Primary] |
| GS1 | 10813954026777 [Package] Contains: 00813954026770 Package: Box [10 Units] In Commercial Distribution |
FDA Product Code
| KGN | Wound Dressing With Animal-Derived Material(S) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-04-03 |
| Device Publish Date | 2025-03-26 |
Devices Manufactured by COLLAGEN MATRIX, INC.
| 00813954026671 - PuraFLEX | 2025-04-03 Collagen Dental Membrane |
| 00813954026688 - PuraFLEX | 2025-04-03 Collagen Dental Membrane |
| 00813954026695 - PuraFLEX | 2025-04-03 Collagen Dental Membrane |
| 00813954026701 - PuraEXTEND | 2025-04-03 Collagen Dental Membrane |
| 00813954026718 - PuraEXTEND | 2025-04-03 Collagen Dental Membrane |
| 00813954026725 - PuraEXTEND | 2025-04-03 Collagen Dental Membrane |
| 10813954026739 - PuraFILL | 2025-04-03 Bone Graft Composite Plug |
| 10813954026746 - PuraFILL | 2025-04-03 Bone Graft Composite Plug |
Trademark Results [PuraKOTE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PURAKOTE 88648464 not registered Live/Pending |
PuraGraft, LLC 2019-10-09 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.