| Primary Device ID | 50732224004308 |
| NIH Device Record Key | d12db787-504d-47e8-8d01-b3cc2b3fd31a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Preminum All-Gauze Sponges |
| Version Model Number | ENC416 |
| Catalog Number | ENC416 |
| Company DUNS | 057728685 |
| Company Name | CROSSTEX INTERNATIONAL, INC. |
| Device Count | 200 |
| DM Exempt | true |
| Pre-market Exempt | false |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00732224004303 [Unit of Use] |
| GS1 | 10732224004300 [Primary] |
| GS1 | 50732224004308 [Package] Contains: 10732224004300 Package: case [10 Units] In Commercial Distribution |
| EFQ | GAUZE/SPONGE, INTERNAL |
| 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 | 2023-07-25 |
| Device Publish Date | 2023-07-17 |
| 50732224004308 | 4" x 4", 16 Ply |
| 50732224004292 | 4" x 4", 12 Ply |
| 50732224004285 | 4" x 4", 8 Ply |
| 50732224004278 | 3" x 3", 12 Ply |
| 50732224004261 | 3" x 3", 8 Ply |
| 50732224004254 | 2" x 2", 12 Ply |