| Primary Device ID | 05000223463113 |
| NIH Device Record Key | 87fd24bf-d322-4126-b983-a9a3e13db6d6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OPSITE POST-OP VISIBLE 20X10CM CTN 20 |
| Version Model Number | 66800138 |
| Catalog Number | 66800138 |
| 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 | 05000223463106 [Primary] |
| GS1 | 05000223463113 [Package] Contains: 05000223463106 Package: Carton [20 Units] In Commercial Distribution |
| GS1 | 05000223463120 [Package] Package: Case [6 Units] In Commercial Distribution |
| KGX | Tape And Bandage, Adhesive |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2023-09-07 |
| Device Publish Date | 2020-09-18 |
| 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 |
| 05000223499402 - RENASYS | 2025-10-01 RENASYS WOUND+ Dressing kit with AIRLOCK Technology with foam, small |
| 05000223504267 - RENASYS | 2025-10-01 RENASYS WOUND+ Dressing kit with AIRLOCK Technology, large |
| 05000223504274 - RENASYS | 2025-10-01 RENASYS WOUND+ Dressing kit with AIRLOCK Technology, medium |
| 05000223504281 - RENASYS | 2025-10-01 RENASYS WOUND+ Dressing kit with AIRLOCK Technology, small |
| 05000223501686 - ALLEVYN™ Ag+ | 2025-08-20 ALLEVYN AG+ 3.9IN X 3.9IN |
| 05000223501693 - ALLEVYN™ Ag+ | 2025-08-20 ALLEVYN AG+ 4.9IN X 4.9IN |