Primary Device ID | 00840117344594 |
NIH Device Record Key | 28a99224-e895-4913-b54c-4bb7ce868461 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Durma+ Island Dressing, 6" x 3 1/8" |
Version Model Number | 3045 |
Company DUNS | 008124539 |
Company Name | Dynarex Corporation |
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 | true |
RX Perscription | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00840117344570 [Package] Contains: 00840117344587 Package: Case [10 Units] In Commercial Distribution |
GS1 | 00840117344587 [Package] Package: Box [20 Units] In Commercial Distribution |
GS1 | 00840117344594 [Primary] |
NAB | Gauze / Sponge,Nonresorbable For External Use |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-06-06 |
Device Publish Date | 2025-05-29 |
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00616784050218 - Pedal Exerciser, Folding, Digital, Hands/Feet | 2025-06-06 |
00840117343689 - Durma+ DynaGinate AG, Calcium Alginate Dressing, 4" x 4" | 2025-06-06 |
00840117344594 - Durma+ Island Dressing, 6" x 3 1/8" | 2025-06-06Sterile-EO |
00840117344594 - Durma+ Island Dressing, 6" x 3 1/8" | 2025-06-06 Sterile-EO |
00840117344624 - Durma+ Island Dressing, 4" x 13 3/4" | 2025-06-06 |
00840117345225 - Resp-O2 Non-Rebreather Elongated Mask, Adult, With Safety Vent, 7'(2.1m) | 2025-06-06 Crush- Resistant Tubing, 1000 mL Reservoir Bag, Universal Connector |
00840117345829 - Durma+ Petrolatum Gauze Dressing, 1" x 8", Neutral Wound, Dressing | 2025-06-06 3% Bismuth Tribromophenate in a Petrolatum Blend, Sterile-R |