| Primary Device ID | 00840117348905 |
| NIH Device Record Key | 19df5ee6-d1c4-4509-ad80-3b82b02c00a2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Post-Op Sponges |
| Version Model Number | 3348 |
| Company DUNS | 008124539 |
| Company Name | Dynarex Corporation |
| Device Count | 2 |
| 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 | false |
| 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 | 00810180844260 [Unit of Use] |
| GS1 | 00840117348905 [Primary] |
| GS1 | 00840117348912 [Package] Package: Box [25 Units] In Commercial Distribution |
| GS1 | 00840117348929 [Package] Contains: 00840117348912 Package: Case [24 Units] In Commercial Distribution |
| NAB | Gauze / Sponge,Nonresorbable For External Use |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2026-03-16 |
| Device Publish Date | 2022-04-28 |
| 00616784334905 | Post-Op Sponges, Non-Woven, Sterile, 4" x 4", 4-Ply (10.2cm x 10.2cm) |
| 00616784334806 | Post-Op Sponges, Non-Woven, Sterile, 4" x 3", 4-Ply (10.2cm x 7.6cm) |
| 00840117348905 | Post-Op Sponges, Non-Woven, Sterile, 4" x 3", 4-Ply (10.2cm x 7.6cm) |