Duns Number:832696038
Device Description: ESMARK BANDAGE 4IN X 9FT 20/BX
Catalog Number
014.00
Brand Name
V. Mueller
Version/Model Number
014.00
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)
Yes
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
56424187-3370-459d-8442-9cacf4bd8b13
Public Version Date
August 13, 2018
Public Version Number
1
DI Record Publish Date
July 12, 2018
Package DI Number
20885403206426
Quantity per Package
20
Contains DI Package
10885403206429
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 8016 |
2 | A medical device with a moderate to high risk that requires special controls. | 6223 |