KBIO® Dura
GUDID 00813954023809
Dural Repair Collagen Matrix 75 x 75 75 x 75mm (3 x 3in)
COLLAGEN MATRIX, INC.
Dura mater biomatrix implant| Primary Device ID | 00813954023809 |
| NIH Device Record Key | af0a799f-bff8-4ce2-a009-1767c1dbb093 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | KBIO® Dura |
| Version Model Number | KBI-DU 03 03-S |
| Company DUNS | 176262442 |
| Company Name | COLLAGEN MATRIX, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| 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
| Width | 75 Millimeter |
| Length | 75 Millimeter |
| Width | 75 Millimeter |
| Length | 75 Millimeter |
| Width | 75 Millimeter |
| Length | 75 Millimeter |
| Width | 75 Millimeter |
| Length | 75 Millimeter |
| Width | 75 Millimeter |
| Length | 75 Millimeter |
| Width | 75 Millimeter |
| Length | 75 Millimeter |
| Width | 75 Millimeter |
| Length | 75 Millimeter |
| Width | 75 Millimeter |
| Length | 75 Millimeter |
| Width | 75 Millimeter |
| Length | 75 Millimeter |
| Width | 75 Millimeter |
| Length | 75 Millimeter |
| Width | 75 Millimeter |
| Length | 75 Millimeter |
| Width | 75 Millimeter |
| Length | 75 Millimeter |
| Width | 75 Millimeter |
| Length | 75 Millimeter |
| Width | 75 Millimeter |
| Length | 75 Millimeter |
| Width | 75 Millimeter |
| Length | 75 Millimeter |
| Width | 75 Millimeter |
| Length | 75 Millimeter |
| Width | 75 Millimeter |
| Length | 75 Millimeter |
| Width | 75 Millimeter |
| Length | 75 Millimeter |
| Width | 75 Millimeter |
| Length | 75 Millimeter |
| Width | 75 Millimeter |
| Length | 75 Millimeter |
| Width | 75 Millimeter |
| Length | 75 Millimeter |
| Width | 75 Millimeter |
| Length | 75 Millimeter |
| Width | 75 Millimeter |
| Length | 75 Millimeter |
| Width | 75 Millimeter |
| Length | 75 Millimeter |
| Width | 75 Millimeter |
| Length | 75 Millimeter |
| Width | 75 Millimeter |
| Length | 75 Millimeter |
| Width | 75 Millimeter |
| Length | 75 Millimeter |
| Width | 75 Millimeter |
| Length | 75 Millimeter |
| Width | 75 Millimeter |
| Length | 75 Millimeter |
| Width | 75 Millimeter |
| Length | 75 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00813954023809 [Primary] |
FDA Product Code
| GXQ | Dura Substitute |
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 | 2020-09-11 |
| Device Publish Date | 2020-09-03 |
On-Brand Devices [KBIO® Dura]
| 00813954023823 | Dural Repair Collagen Matrix 125 x 175 125 x 175mm (5 x 7in) |
| 00813954023816 | Dural Repair Collagen Matrix 100 x 125 100 x 125mm (4 x 5in) |
| 00813954023809 | Dural Repair Collagen Matrix 75 x 75 75 x 75mm (3 x 3in) |
| 00813954023793 | Dural Repair Collagen Matrix 50 x 50 50 x 50mm (2 x 2in) |
| 00813954023786 | Dural Repair Collagen Matrix 25 x 75 25 x 75mm (1 x 3in) |
| 00813954023779 | Dural Repair Collagen Matrix 25 x 25 25 x 25mm (1 x 1in) |
Trademark Results [KBIO]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 KBIO 97703714 not registered Live/Pending |
BEST VALUE KOSHER FOOD CORPORATION 2022-12-05 |
 KBIO 79320502 not registered Live/Pending |
British American Tobacco (Brands) Limited 2021-06-09 |
 KBIO 79319351 not registered Live/Pending |
British American Tobacco (Brands) Limited 2021-06-09 |
 KBIO 79128435 4423655 Live/Registered |
SPINEART S.A. 2013-03-26 |
© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.