| Primary Device ID | 04052199575957 |
| NIH Device Record Key | 244d631a-57b2-44b9-a0fb-7b4664486a74 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Omnifix silicone, 10cmx5m, P1 |
| Version Model Number | 9000010 |
| Company DUNS | 010137511 |
| Company Name | HARTMANN USA, INC. |
| 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 | true |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04052199575940 [Primary] |
| GS1 | 04052199575957 [Package] Contains: 04052199575940 Package: [12 Units] In Commercial Distribution |
| KGX | Tape And Bandage, Adhesive |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-09-15 |
| Device Publish Date | 2022-09-07 |
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