| Primary Device ID | 20749915002528 |
| NIH Device Record Key | f503338b-a84b-4a43-8fbb-271434a5295d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ophthalmic Pledget |
| Version Model Number | 111-01 |
| Company DUNS | 151054954 |
| Company Name | AMERICAN SURGICAL COMPANY, LLC |
| Device Count | 20 |
| 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 | 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 | 10749915002521 [Unit of Use] |
| GS1 | 20749915002528 [Primary] |
| HOZ | Sponge, Ophthalmic |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-11-19 |
| Device Publish Date | 2018-10-17 |
| 00749915002937 - Atlas Choice Microsurgery Pattie Collection | 2021-12-17 Atlas Choice Microsurgery Pattie Collection |
| 00749915002944 - Atlas Choice Cranial Pattie Collection | 2021-12-17 Atlas Choice Cranial Pattie Collection |
| 10749915002842 - Tapered Delicot | 2021-09-03 Tapered Delicot 6 mm x 19 mm x 51 mm |
| 10749915002866 - Tapered Delicot | 2021-09-03 Tapered Delicot 6 mm x 19 mm x 51 mm |
| 10749915002880 - Tapered Delicot | 2021-09-03 Tapered Delicot 19 mm x 25 mm x 25 mm |
| 10749915002903 - Tapered Delicot | 2021-09-03 Tapered Delicot 19 mm x 25 mm x 76 mm |
| 20749915002733 - Tapered Delicot | 2021-06-09 Tapered Delicot 3 mm x 6 mm x 48 mm |
| 10749915002767 - Tapered Delicot | 2021-06-09 Tapered Delicot 4 mm x 9 mm x 48 mm |