| Primary Device ID | 20815878027592 |
| NIH Device Record Key | ff32b51c-dbdd-4a7e-b0c7-2a8aa5369770 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Burkhart Cotton Rolls |
| Version Model Number | DNACBK |
| Company DUNS | 057728685 |
| Company Name | CROSSTEX INTERNATIONAL, INC. |
| Device Count | 2000 |
| DM Exempt | false |
| 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 | true |
| 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 | 00815878027598 [Unit of Use] |
| GS1 | 10815878027595 [Primary] |
| GS1 | 20815878027592 [Package] Contains: 10815878027595 Package: Case [12 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 | 2024-04-17 |
| Device Publish Date | 2024-04-09 |
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| 00732224005690 - Crosstex | 2024-04-29 Soft Adaptors for Hygoformic Saliva Ejectors |
| 00732224721484 - Sporview 10 Hour Self Contained BI | 2024-04-18 For use in biologically monitoring steam sterilizers |
| 20815878025321 - Burkhart Non-Woven Sponges | 2024-04-17 |
| 20815878027585 - Burkhart Non-Woven Sponges | 2024-04-17 |
| 20815878027592 - Burkhart Cotton Rolls | 2024-04-17 |
| 20815878027592 - Burkhart Cotton Rolls | 2024-04-17 |