| Primary Device ID | 05000223449049 |
| NIH Device Record Key | bebee443-842d-4546-8bdd-6420b6e7c85e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LEUKOSTRIP 6.4X76MM CTN 50 |
| Version Model Number | 66002878 |
| Catalog Number | 66002878 |
| 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 | true |
| 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 | 05000223449032 [Primary] |
| GS1 | 05000223449049 [Package] Contains: 05000223449032 Package: Carton [50 Units] In Commercial Distribution |
| GS1 | 05000223449056 [Package] Package: Case [4 Units] In Commercial Distribution |
| MZR | Topical Approximation System |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-04-17 |
| Device Publish Date | 2020-04-09 |
| 05000223504151 - BIOBRANE | 2025-03-11 BIOBRANE DRESSING - SMALL GLOVE US |
| 05000223504168 - BIOBRANE | 2025-03-11 BIOBRANE DRESSING - MEDIUM GLOVE US |
| 05000223504175 - BIOBRANE | 2025-03-11 BIOBRANE DRESSING - LARGE GLOVE US |
| 05000223504182 - BIOBRANE | 2025-03-11 BIOBRANE DRESSING - PEDIATRIC GLOVE US |
| 05000223504113 - BIOBRANE | 2025-03-10 BIOBRANE DRESSING 5.1INX5.1IN CTN 5 US |
| 05000223504137 - BIOBRANE | 2025-03-10 BIOBRANE DRESSING 9.8INX15IN CTN 1 US |
| 05000223504144 - BIOBRANE | 2025-03-10 BIOBRANE DRESSING 15INX19.7IN CTN 1 US |
| 05000223504120 - BIOBRANE | 2025-03-07 BIOBRANE DRESSING 5.1INX15IN CTN 5 (US) |