| Primary Device ID | 05000223441227 |
| NIH Device Record Key | 1c79fb16-5a90-45f0-972f-3b39c20e8ba1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OPSITE POST OP 6.5X5CM CTN 100 |
| Version Model Number | 66000708 |
| Catalog Number | 66000708 |
| 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 | 05000223441210 [Primary] |
| GS1 | 05000223441227 [Package] Contains: 05000223441210 Package: Carton [100 Units] In Commercial Distribution |
| GS1 | 05000223441234 [Package] Package: Case [18 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 |
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| 05000223049249 - IV3000 6X8.5CM-CARTON OF 10 | 2023-09-07 Moisture responsive IV catheter dressing |
| 05000223049256 - IV3000 | 2023-09-07 Moisture responsive catheter dressing. 10cm x 14cm Ctn of 10 |
| 05000223463113 - OPSITE POST-OP VISIBLE 20X10CM CTN 20 | 2023-09-07 Waterproof, bacteria proof dressing with absorbent see through pad |
| 00040565122564 - IODOSORB | 2023-09-07 Cadexomer iodine gel. 10g. Ctn of 1 Tube |
| 05000223500184 - RENASYS | 2023-09-07 Renasys XL Transparent Film Dressing |
| 05000223500207 - RENASYS | 2023-09-07 Renasys-F XL Foam Dressing Kit With Soft Port |
| 30040565118254 - IV3000 | 2023-09-07 4” x 5” Non-Sterile Bulk |