Duns Number:200564891
Device Description: 6 in X 145 in relaxed, non-sterile conforming bandage
Catalog Number
DUP75116-5
Brand Name
DuForm®
Version/Model Number
75116-5
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
FQM
Product Code Name
BANDAGE, ELASTIC
Public Device Record Key
ee4b2e79-673f-4267-90da-2ce4bd85c1b0
Public Version Date
September 24, 2021
Public Version Number
2
DI Record Publish Date
October 17, 2018
Package DI Number
00809958077122
Quantity per Package
8
Contains DI Package
00809958077115
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 |