Primary Device ID | 00361554003238 |
NIH Device Record Key | d68d3e24-ac8a-44b0-b8f2-6206f6bae6fc |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Oil Emulsion Dressing (3 x 3 in) |
Version Model Number | GEN-19000 |
Catalog Number | GEN-19000 |
Company DUNS | 170967876 |
Company Name | Gentell, LLC |
Device Count | 25 |
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 | true |
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 | 00361554000206 [Unit of Use] |
GS1 | 00361554003221 [Primary] |
GS1 | 00361554003238 [Package] Contains: 00361554003221 Package: Case [8 Units] In Commercial Distribution |
NAD | Dressing, Wound, Occlusive |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-03-25 |
Device Publish Date | 2025-03-17 |
00361554007229 - Gentell | 2025-09-03 GEN13022 Gelling Fiber Ag Dressing 2”x2” (5cmx5cm) |
00361554007250 - Gentell | 2025-09-03 GEN13044 Gelling Fiber Ag Dressing 4”x4” (10cmx10cm) |
00361554007182 - Gentell | 2025-09-03 GEN13066 Gelling Fiber Ag Dressing 6”x6” (15cmx15cm) |
00361554003375 - Gentell | 2025-08-29 GEN13020 Gelling Fiber Dressing 2”x2” (5cmx5cm) |
00361554001098 - Gentell | 2025-08-29 GEN13040 Gelling Fiber Dressing 4”x4” (10cmx10cm) |
00361554001128 - Gentell | 2025-08-29 GEN13060 Gelling Fiber Dressing 6”x6” (15cmx15cm) |
15056860000072 - Gentell Hydrogel Sheet Dressing | 2025-08-29 GEN-11470 Gentell Hydrogel Sheet Dressing, 120mm x 86mm (4.7” x 3.4”), Borderless |
15056860000089 - Gentell Hydrogel Sheet Dressing | 2025-08-29 GEN-11700 Gentell Hydrogel Sheet Dressing, 178mm x 127mm (7” x 5”), Borderless |