| Primary Device ID | 20749915000654 |
| NIH Device Record Key | c5e44066-4372-40b7-85dd-b5b0eeb97a44 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cotton Balls |
| Version Model Number | 31-04 |
| Company DUNS | 151054954 |
| Company Name | AMERICAN SURGICAL COMPANY, LLC |
| Device Count | 20 |
| 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 | 10749915000657 [Unit of Use] |
| GS1 | 20749915000654 [Primary] |
| GDY | Gauze/Sponge, Internal, X-Ray Detectable |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-11-25 |
| Device Publish Date | 2016-06-07 |
| 30749915000613 | Cotton Balls-Non-Strung 1/4" |
| 30749915000538 | Cotton Balls-Strung 3/8" |
| 20749915000685 | Cotton Balls-Non-Strung 1/8" |
| 20749915000678 | Cotton Balls-Non-Strung 2" |
| 20749915000661 | Cotton Balls-Non-Strung 1.25" |
| 20749915000654 | Cotton Balls-Non-Strung 1" |
| 20749915000647 | Cotton Balls-Non-Strung 3/4" |
| 20749915000630 | Cotton Balls-Non-Strung 1/2" |
| 20749915000623 | Cotton Balls-Non-Strung 3/8" |
| 20749915000609 | Cotton Balls-Strung 1/8" |
| 20749915000593 | Cotton Balls-Strung 2" |
| 20749915000586 | Cotton Balls-Strung 1.25" |
| 20749915000562 | Cotton Balls-Strung 1" |
| 20749915000555 | Cotton Balls-Strung 3/4" |
| 20749915000548 | Cotton Balls-Strung 1/2" |
| 20749915000517 | Cotton Balls-Strung 1/4" |