Duns Number:216344051
Device Description: Absorbent, waterproof, bacteria proof film dressing
Catalog Number
66000713
Brand Name
OPSITE POST OP 20X10CM CTN 20
Version/Model Number
66000713
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
e6824a3a-db62-450b-aa4e-7e64f5c2bc3c
Public Version Date
February 22, 2021
Public Version Number
1
DI Record Publish Date
February 12, 2021
Package DI Number
05000223441371
Quantity per Package
20
Contains DI Package
05000223441364
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 |