| Primary Device ID | 00813954024639 |
| NIH Device Record Key | 57de7f1b-b0c1-45c9-a572-9792657c7509 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PLENA MEDIUM |
| Version Model Number | PDM2030 |
| 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 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 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00813954024639 [Primary] |
| NPL | Barrier, Animal Source, Intraoral |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-03-21 |
| Device Publish Date | 2022-03-11 |
| 00813954024646 | Regenerative Collagen Dental Membrane 30mm x 40mm |
| 00813954024639 | Regenerative Collagen Dental Membrane 20mm x 30mm |
| 00813954024622 | Regenerative Collagen Dental Membrane 15mm x 20mm |
| 00813954027104 | Regenerative Collagen Dental Membrane |
| 00813954027098 | Regenerative Collagen Dental Membrane |