Duns Number:324869601
Device Description: Esmarch Bandage
Catalog Number
-
Brand Name
n.a.
Version/Model Number
20-20-080
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"
-
For Single-Use
-
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
adda088f-2be7-4cbd-9928-cd94b5d83035
Public Version Date
September 06, 2022
Public Version Number
4
DI Record Publish Date
June 04, 2020
Package DI Number
14250105605683
Quantity per Package
5
Contains DI Package
04250105605686
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 334 |
2 | A medical device with a moderate to high risk that requires special controls. | 14 |