Duns Number:216344051
Device Description: Impregnated Gauze Dressing
Catalog Number
66045560
Brand Name
CUTICERIN 7.5X7.5CM CTN 50
Version/Model Number
66045560
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K842967,K842967,K842967
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
e9226f29-cf04-4afe-ab8a-3abef7c92f16
Public Version Date
December 02, 2020
Public Version Number
1
DI Record Publish Date
November 24, 2020
Package DI Number
05000223450168
Quantity per Package
50
Contains DI Package
05000223450151
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 |