Duns Number:216344051
Device Description: Waterproof, bacteria proof dressing with absorbent see through pad
Catalog Number
66800141
Brand Name
Opsite Post-Op Visible 35x10cm Ctn 20
Version/Model Number
66800141
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
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
4c6e3466-ae42-4890-b930-43e7756e2fee
Public Version Date
July 08, 2020
Public Version Number
2
DI Record Publish Date
May 15, 2020
Package DI Number
05000223468699
Quantity per Package
20
Contains DI Package
05000223468637
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
carton
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 63 |
2 | A medical device with a moderate to high risk that requires special controls. | 126 |
U | Unclassified | 1 |