Durepair®
GUDID 00643169063907
DURA 62158 SUBSTITUTE DUREPAIR 5X8IN NCE
MEDTRONIC PS MEDICAL, INC.
Dura mater graft, bovine Dura mater graft, bovine Dura mater graft, bovine Dura mater graft, bovine Dura mater graft, bovine Dura mater graft, bovine Dura mater graft, bovine Dura mater graft, bovine Dura mater graft, bovine Dura mater graft, bovine Dura mater graft, bovine Dura mater graft, bovine Dura mater graft, bovine| Primary Device ID | 00643169063907 |
| NIH Device Record Key | 9855a25d-55c7-46cc-899d-8b780c789c7a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Durepair® |
| Version Model Number | 62158 |
| Company DUNS | 089055867 |
| Company Name | MEDTRONIC PS MEDICAL, 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 | false |
| 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 | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
Device Dimensions
| Length | 20.3 Centimeter |
| Length | 20.3 Centimeter |
| Length | 20.3 Centimeter |
| Length | 20.3 Centimeter |
| Width | 12.5 Centimeter |
| Length | 20.3 Centimeter |
| Width | 12.5 Centimeter |
| Length | 20.3 Centimeter |
| Width | 12.5 Centimeter |
| Length | 20.3 Centimeter |
| Width | 12.5 Centimeter |
| Length | 20.3 Centimeter |
| Width | 12.5 Centimeter |
| Length | 20.3 Centimeter |
| Width | 12.5 Centimeter |
| Length | 20.3 Centimeter |
| Width | 12.5 Centimeter |
| Length | 20.3 Centimeter |
| Width | 12.5 Centimeter |
| Length | 20.3 Centimeter |
| Width | 12.5 Centimeter |
| Length | 20.3 Centimeter |
| Width | 12.5 Centimeter |
| Length | 20.3 Centimeter |
| Width | 12.5 Centimeter |
| Length | 20.3 Centimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat sources |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat sources |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat sources |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat sources |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat sources |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat sources |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat sources |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat sources |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat sources |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat sources |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat sources |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169063907 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K063117
FDA Product Code
| GXQ | DURA SUBSTITUTE |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-06-24 |
On-Brand Devices [Durepair®]
| 00643169063907 | DURA 62158 SUBSTITUTE DUREPAIR 5X8IN NCE |
| 00643169063891 | DURA 62111 SUBSTITUTE DUREPAIR 1X1IN NCE |
| 00643169063884 | DURA 62110 SUBSTITUTE DUREPAIR 4X5IN NCE |
| 00643169063877 | DURA 62106 SUBSTITUTE DUREPAIR 1X3IN NCE |
| 00643169063860 | DURA 62105 SUBSTITUTE DUREPAIR 3X3IN NCE |
| 00643169063853 | DURA 62100 SUBSTITUTE DUREPAIR 2X2IN NCE |
Trademark Results [Durepair]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DUREPAIR 78015607 2813992 Live/Registered |
TEI BIOSCIENCE INC. 2000-07-06 |
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