| Primary Device ID | 50732224005206 |
| NIH Device Record Key | 5030a444-84a1-4f07-92ff-94f3be22ac3d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Premium Non-Woven Sponges |
| Version Model Number | ENCNW4K |
| Catalog Number | ENCNW4K |
| Company DUNS | 057728685 |
| Company Name | CROSSTEX INTERNATIONAL, INC. |
| Device Count | 200 |
| DM Exempt | true |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00732224005201 [Unit of Use] |
| GS1 | 10732224005208 [Primary] |
| GS1 | 50732224005206 [Package] Contains: 10732224005208 Package: case [10 Units] In Commercial Distribution |
| 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 |
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