| Primary Device ID | 20749915000456 |
| NIH Device Record Key | 34b44edd-4ee7-4a0c-b447-2be883de95d8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ultracot |
| Version Model Number | 23-10 |
| 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 | 10749915000459 [Unit of Use] |
| GS1 | 20749915000456 [Primary] |
| HBA | Neurosurgical Paddie |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-06-06 |
| 20749915000500 | Ultracot 70 mm x 100 mm |
| 20749915000494 | Ultracot 10 mm x 80 mm |
| 20749915000487 | Ultracot 20 mm x 50 mm |
| 20749915000470 | Ultracot 30 mm x 90 mm |
| 20749915000463 | Ultracot 15 mm x 15 mm |
| 20749915000456 | Ultracot 30 mm x 70 mm |
| 20749915000449 | Ultracot 20 mm x 60 mm |
| 20749915000432 | Ultracot 13 mm x 60 mm |
| 20749915000425 | Ultracot 9 mm x 50 mm |
| 20749915000418 | Ultracot 6 mm x 50 mm |
| 20749915000401 | Ultracot 4 mm x 50 mm |
| 20749915000395 | Ultracot 15 mm x 20 mm |
| 20749915000388 | Ultracot 10 mm x 13 mm |
| 20749915000371 | Ultracot 5 mm x 13 mm |
| 20749915000364 | Ultracot 5 mm x 8 mm |