Duns Number:080361159
Device Description: CAMOUFLAGE COLOR BANDAGE, COHESIVE, 2"X5 YARDS, EA
Catalog Number
-
Brand Name
DYNAMIC DIAGNOSTICS CAMOUFLAGE COHESIVE BANDAGE
Version/Model Number
JK2442-CAMO
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
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
ITG
Product Code Name
Bandage, Cast
Public Device Record Key
b9652a59-721b-45ef-b6f2-966d65625d87
Public Version Date
August 09, 2022
Public Version Number
1
DI Record Publish Date
August 01, 2022
Package DI Number
10840216101651
Quantity per Package
36
Contains DI Package
00840216101654
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner Pack
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 1046 |
2 | A medical device with a moderate to high risk that requires special controls. | 23 |
U | Unclassified | 2 |