| Primary Device ID | 10856040008110 |
| NIH Device Record Key | 7b9c0e4e-3772-4d61-92b8-2c338eeb5973 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TheraBond 3D antimicrobial barrier systems |
| Version Model Number | 3DAI-46 |
| Company DUNS | 091449079 |
| Company Name | ARGENTUM MEDICAL, LLC |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00856040008113 [Primary] |
| GS1 | 10856040008110 [Package] Contains: 00856040008113 Package: [5 Units] In Commercial Distribution |
| FRO | Dressing, Wound, Drug |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-10-08 |
| Device Publish Date | 2020-09-30 |
| 10856040008165 | 3D Wrap Dressing 6in x 96in |
| 10856040008158 | 3D Wrap Dressing 4in x 72in |
| 10856040008141 | 3D XS Island Dressing 4in x 14in |
| 10856040008134 | 3D XS Island Dressing 4in x 10in |
| 10856040008127 | 3D Island Dressing 4in x 8in |
| 10856040008110 | 3D Island Dressing 4in x 6in |
| 10856040008103 | 3D Island Dressing 4in x 5in |
| 10856040008097 | 3D Island Dressing 4in x 12in |
| 10856040008080 | 3D Island Dressing 4in x 10in |
| 10856040008073 | 3D Island Dressing 2in x 2in |
| 10856040008066 | 3D Contact Dressing 8in x 16in |
| 10856040008059 | 3D Contact Dressing 4in x 8in |
| 10856040008042 | 3D Contact Dressing 4.25in x 4.25in |
| 10856040008035 | 3D Contact Dressing 24in x 24in |
| 10856040008028 | 3D Contact Dressing 16in x 16in |
| 10856040008011 | 3D Contact Dressing 1.5in x 6in |
| 00856040008007 | 3D Contact Dressing 1.5in x 10in |