| Primary Device ID | 30040565115277 |
| NIH Device Record Key | 345dbe97-3913-4199-ab93-932802c88e22 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SOLOSITE |
| Version Model Number | 449600 |
| Catalog Number | 449600 |
| 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 | false |
| 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 | 00040565115276 [Primary] |
| GS1 | 30040565115277 [Package] Contains: 00040565115276 Package: Case [12 Units] In Commercial Distribution |
| NAE | Dressing, Wound, Hydrogel Without Drug And/Or Biologic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2023-09-07 |
| Device Publish Date | 2023-01-31 |
| 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 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SOLOSITE 74372627 1847222 Live/Registered |
SMITH & NEPHEW, INC. 1993-03-29 |
![]() SOLOSITE 74014846 not registered Dead/Abandoned |
Smith and Nephew United Inc. 1989-12-28 |