Duns Number:200564891
Device Description: 18 in X 72 in 2 ply burn dressing folded into 3 in X 8 in - 96 ply. Sterile.
Catalog Number
DUP8136S
Brand Name
Dupress®
Version/Model Number
8136S
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NAB
Product Code Name
Gauze / sponge,nonresorbable for external use
Public Device Record Key
ea790548-e7ca-49e1-a70b-4acd01c1e042
Public Version Date
August 24, 2021
Public Version Number
2
DI Record Publish Date
March 08, 2019
Package DI Number
00809958085127
Quantity per Package
50
Contains DI Package
00809958085134
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 254 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |
| U | Unclassified | 42 |