| Primary Device ID | 00813954024592 |
| NIH Device Record Key | 9f21a90e-13e6-4118-b9a7-f6807885b3cc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PLENA FLEX |
| Version Model Number | CDMPP1520 |
| 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 | 00813954024592 [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 |
| 00813954024615 | Resorbable Collagen Membrane For Dental Surgery 30mm x 40mm |
| 00813954024608 | Resorbable Collagen Membrane For Dental Surgery 20mm x 30mm |
| 00813954024592 | Resorbable Collagen Membrane For Dental Surgery 15mm x 20mm |
| 00813954027043 | Resorbable Collagen Membrane for Dental Surgery |
| 00813954027036 | Resorbable Collagen Membrane for Dental Surgery |