| Primary Device ID | 04052199578224 |
| NIH Device Record Key | 0366f293-0093-4dc6-a47d-35bd081585ec |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cosmopor Silicone Island Dressing 14” x 4” / 35cm x 10cm |
| Version Model Number | 901110 |
| 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04052199578217 [Primary] |
| GS1 | 04052199578224 [Package] Contains: 04052199578217 Package: [10 Units] In Commercial Distribution |
| GS1 | 04052199578231 [Package] Package: [12 Units] In Commercial Distribution |
| KGX | Tape And Bandage, Adhesive |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-03-08 |
| Device Publish Date | 2023-02-28 |
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