DuraMend™
GUDID 00813954022499
Collagen Dura Substitute Membrane 4in x 5in (10.0cm x 12.5cm)
COLLAGEN MATRIX, INC.
Dura mater biomatrix implant| Primary Device ID | 00813954022499 |
| NIH Device Record Key | 059f82d3-9240-4cb2-9897-d5cdfd9a6402 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DuraMend™ |
| Version Model Number | NDM45 |
| 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 |
Device Dimensions
| Length | 5 Inch |
| Length | 5 Inch |
| Length | 5 Inch |
| Length | 5 Inch |
| Width | 4 Inch |
| Length | 5 Inch |
| Width | 4 Inch |
| Length | 5 Inch |
| Width | 4 Inch |
| Length | 5 Inch |
| Width | 4 Inch |
| Length | 5 Inch |
| Width | 4 Inch |
| Length | 5 Inch |
| Width | 4 Inch |
| Length | 5 Inch |
| Width | 4 Inch |
| Length | 5 Inch |
| Width | 4 Inch |
| Length | 5 Inch |
| Width | 4 Inch |
| Length | 5 Inch |
| Width | 4 Inch |
| Length | 5 Inch |
| Width | 4 Inch |
| Length | 5 Inch |
| Width | 4 Inch |
| Length | 5 Inch |
| Width | 4 Inch |
| Length | 5 Inch |
| Width | 4 Inch |
| Length | 5 Inch |
| Width | 4 Inch |
| Length | 5 Inch |
| Width | 4 Inch |
| Length | 5 Inch |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00813954022499 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K040888
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 | 2019-11-11 |
| Device Publish Date | 2018-04-05 |
On-Brand Devices [DuraMend™]
| 00813954022499 | Collagen Dura Substitute Membrane 4in x 5in (10.0cm x 12.5cm) |
| 00813954022482 | Collagen Dura Substitute Membrane 3in x 3in (7.5cm x 7.5cm) |
| 00813954022475 | Collagen Dura Substitute Membrane 2in x 2in (5.0cm x 5.0cm) |
| 00813954022468 | Collagen Dura Substitute Membrane 1in x 3in (2.5cm x 7.5cm) |
| 00813954022451 | Collagen Dura Substitute Membrane 1in x 1in (2.5cm x 2.5cm) |
Trademark Results [DuraMend]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DURAMEND 87530951 not registered Live/Pending |
Collagen Matrix, Inc. 2017-07-17 |
 DURAMEND 76478176 not registered Dead/Abandoned |
JOHNSON & JOHNSON 2002-12-13 |
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