Primary Device ID | 05000223438517 |
NIH Device Record Key | 8584ce2e-d2e0-4bed-bf2c-3d0ec61ed137 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | OPSITE FLEXIGRID USA 10X12CM CARTON OF 10 |
Version Model Number | 66024629, 66024630 |
Catalog Number | 66024629, 66024630 |
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 | 05000223046293 [Package] Contains: 05000223415419 Package: Carton 4629 [10 Units] In Commercial Distribution |
GS1 | 05000223046309 [Package] Contains: 05000223415419 Package: Carton 4630 [50 Units] In Commercial Distribution |
GS1 | 05000223415419 [Primary] |
GS1 | 05000223438517 [Package] Contains: 05000223415419 Package: Carton 66024629 [10 Units] In Commercial Distribution |
GS1 | 05000223438524 [Package] Contains: 05000223415419 Package: Carton 66024630 [50 Units] In Commercial Distribution |
GS1 | 05000223438722 [Package] Contains: 05000223438524 Package: Case 66024630 [4 Units] In Commercial Distribution |
GS1 | 05000223464257 [Package] Contains: 05000223046293 Package: Case 4629 [8 Units] In Commercial Distribution |
GS1 | 05000223464264 [Package] Contains: 05000223046309 Package: Case 4630 [8 Units] In Commercial Distribution |
GS1 | 05000223464271 [Package] Package: Case 66024629 [8 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 | 2021-06-14 |
Device Publish Date | 2021-06-04 |
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) |