| Primary Device ID | 10684995300313 |
| NIH Device Record Key | 7d9f004e-ba0d-4065-bd57-d12bc5e0373d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Silicone Sheeting, Non-Reinforced |
| Version Model Number | PR72034-60N |
| Company DUNS | 080524654 |
| Company Name | BENTEC MEDICAL OPCO, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00684995300316 [Primary] |
| GS1 | 10684995300313 [Package] Contains: 00684995300316 Package: [2 Units] In Commercial Distribution |
| NAD | Dressing, Wound, Occlusive |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-10-30 |
| Device Publish Date | 2023-10-20 |
| 00684995200135 - Silicone Block | 2023-10-30 Soft, 0.5'' x 1'' x 1'' |
| 00684995200142 - Silicone Block | 2023-10-30 Firm, 0.5'' x 1'' x 1'' |
| 00684995200159 - Silicone Block | 2023-10-30 X-Firm, 0.5'' x 1'' x 1'' |
| 10684995300313 - Silicone Sheeting, Non-Reinforced | 2023-10-300.005'' x 2'' x 2'' |
| 10684995300313 - Silicone Sheeting, Non-Reinforced | 2023-10-30 0.005'' x 2'' x 2'' |
| 00684995310261 - Silicone Sheeting, Reinforced | 2023-10-30 0.015" x 12" x 14" |
| 00684995510005 - Silicone T-Tube | 2023-10-30 4 Fr. x 12 in L |
| 00684995510012 - Silicone T-Tube | 2023-10-30 6 Fr. x 12 in L |
| 00684995510029 - Silicone T-Tube | 2023-10-30 8 Fr. x 12 in L |