Duns Number:041674552
Device Description: Self-Adherent Wrap-3x5yd,Black
Catalog Number
Not Applicable
Brand Name
Elite Self-Adherent Wrap
Version/Model Number
ELITE-17113
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
KGX
Product Code Name
Tape And Bandage, Adhesive
Public Device Record Key
25a2b02e-b73f-4618-8fef-e136afc2003e
Public Version Date
April 27, 2021
Public Version Number
1
DI Record Publish Date
April 19, 2021
Package DI Number
00840155407589
Quantity per Package
16
Contains DI Package
00816703023082
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 | 498 |
2 | A medical device with a moderate to high risk that requires special controls. | 90 |