| Primary Device ID | 00840117344624 |
| NIH Device Record Key | 0c4589d0-f5c0-4cef-b112-e3afe759c8e2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Durma+ Island Dressing, 4" x 13 3/4" |
| Version Model Number | 3074 |
| Company DUNS | 008124539 |
| Company Name | Dynarex Corporation |
| 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 | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840117344600 [Package] Contains: 00840117344617 Package: Case [10 Units] In Commercial Distribution |
| GS1 | 00840117344617 [Package] Package: Box [20 Units] In Commercial Distribution |
| GS1 | 00840117344624 [Primary] |
| NAB | Gauze / Sponge,Nonresorbable For External Use |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-06-06 |
| Device Publish Date | 2025-05-29 |
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