| Primary Device ID | 05000223441340 |
| NIH Device Record Key | 461c4dd8-c4b1-496b-b0bf-00146d8aac17 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OPSITE POST OP 15.5X8.5CM CTN 20 |
| Version Model Number | 66000712 |
| Catalog Number | 66000712 |
| Company DUNS | 216344051 |
| Company Name | SMITH & NEPHEW MEDICAL LIMITED |
| Device Count | 1 |
| 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 | 05000223441333 [Primary] |
| GS1 | 05000223441340 [Package] Contains: 05000223441333 Package: Carton [20 Units] In Commercial Distribution |
| GS1 | 05000223441357 [Package] Package: Case [10 Units] In Commercial Distribution |
| KGX | Tape And Bandage, Adhesive |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-02-22 |
| Device Publish Date | 2021-02-12 |
| 00040565117706 - COVRSITE | 2026-01-27 COVRSITE DRESSING 4X4 BOX 10 |
| 00040565117744 - COVRSITE | 2026-01-27 CovRSite Dressing 6 x 6 CTN10 |
| 00040565120256 - COVRSITE | 2026-01-27 CovRSite Plus Dressing 4 x 4 CTN10 |
| 00040565120270 - COVRSITE | 2026-01-27 CovRSite Plus Dressing 6 x 6 CTN10 |
| 00500223504335 - NOVIX | 2026-01-21 NOVIX PRIMER AND CLEANSER 4OZ |
| 05000223502713 - No Sting Skin Prep | 2025-12-04 NO-STING SKIN PREP SPRAY 28ML US |
| 05000223499389 - RENASYS | 2025-10-01 RENASYS WOUND+ Dressing kit with AIRLOCK Technology with foam, large |
| 05000223499396 - RENASYS | 2025-10-01 RENASYS WOUND+ Dressing kit with AIRLOCK Technology with foam, medium |