Duns Number:080070945
Device Description: Protect U Guard Flexible Fabric Adhesive Bandages 5.6x1.9cm
Catalog Number
-
Brand Name
Protect U Guard Flexible Fabric Adhesive Bandages
Version/Model Number
P19140
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
Yes
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
99c05be2-aa4b-43da-9027-e131ff6ef4b1
Public Version Date
August 31, 2020
Public Version Number
1
DI Record Publish Date
August 21, 2020
Package DI Number
B086291402
Quantity per Package
15000
Contains DI Package
B086191401
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CARTON