Durepair®
GUDID 00643169063860
DURA 62105 SUBSTITUTE DUREPAIR 3X3IN NCE
MEDTRONIC PS MEDICAL, INC.
Dura mater graft, bovine| Primary Device ID | 00643169063860 |
| NIH Device Record Key | 365f2bfe-1a68-4df2-aaaa-cb168aca197b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Durepair® |
| Version Model Number | 62105 |
| 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
Device Dimensions
| Length | 7.5 Centimeter |
| Length | 7.5 Centimeter |
| Length | 7.5 Centimeter |
| Length | 7.5 Centimeter |
| Width | 7.5 Centimeter |
| Length | 7.5 Centimeter |
| Width | 7.5 Centimeter |
| Length | 7.5 Centimeter |
| Width | 7.5 Centimeter |
| Length | 7.5 Centimeter |
| Width | 7.5 Centimeter |
| Length | 7.5 Centimeter |
| Width | 7.5 Centimeter |
| Length | 7.5 Centimeter |
| Width | 7.5 Centimeter |
| Length | 7.5 Centimeter |
| Width | 7.5 Centimeter |
| Length | 7.5 Centimeter |
| Width | 7.5 Centimeter |
| Length | 7.5 Centimeter |
| Width | 7.5 Centimeter |
| Length | 7.5 Centimeter |
| Width | 7.5 Centimeter |
| Length | 7.5 Centimeter |
| Width | 7.5 Centimeter |
| Length | 7.5 Centimeter |
| Width | 7.5 Centimeter |
| Length | 7.5 Centimeter |
| Width | 7.5 Centimeter |
| Length | 7.5 Centimeter |
| Width | 7.5 Centimeter |
| Length | 7.5 Centimeter |
| Width | 7.5 Centimeter |
| Length | 7.5 Centimeter |
| Width | 7.5 Centimeter |
| Length | 7.5 Centimeter |
| Width | 7.5 Centimeter |
| Length | 7.5 Centimeter |
| Width | 7.5 Centimeter |
| Length | 7.5 Centimeter |
| Width | 7.5 Centimeter |
| Length | 7.5 Centimeter |
| Width | 7.5 Centimeter |
| Length | 7.5 Centimeter |
| Width | 7.5 Centimeter |
| Length | 7.5 Centimeter |
| Width | 7.5 Centimeter |
| Length | 7.5 Centimeter |
| Width | 7.5 Centimeter |
| Length | 7.5 Centimeter |
| Width | 7.5 Centimeter |
| Length | 7.5 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 |
| 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 |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169063860 [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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