| Primary Device ID | 05000223441814 |
| NIH Device Record Key | ae6b2f41-4bf0-4308-b4a0-2e18162041c2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CICA-CARE 15CM X 12CM |
| Version Model Number | 66250706, 66250707 |
| Catalog Number | 66250706, 66250707 |
| 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 | 05000223441579 [Primary] |
| GS1 | 05000223441654 [Package] Contains: 05000223441579 Package: Carton 66250707 [10 Units] In Commercial Distribution |
| GS1 | 05000223441814 [Package] Contains: 05000223441579 Package: Carton 66250706 [1 Units] In Commercial Distribution |
| GS1 | 05000223441821 [Package] Package: Case 66250706 [5 Units] In Commercial Distribution |
| GS1 | 05000223498351 [Package] Contains: 05000223441654 Package: Case 66250707 [1 Units] In Commercial Distribution |
| MDA | Elastomer, Silicone, For Scar Management |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-02-22 |
| Device Publish Date | 2021-02-12 |
| 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 |