Duns Number:830016148
Device Description: 3M™ Cavilon™ No Sting Barrie Film 50 Wipes/Carton 8 Cartons/Case 3342
Catalog Number
3342
Brand Name
3M™ Cavilon™
Version/Model Number
3342
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K955103,K955103,K955103
Product Code
KMF
Product Code Name
Bandage, liquid
Public Device Record Key
11707d22-edaa-43f7-bdbb-adacc2a6c8f0
Public Version Date
October 25, 2018
Public Version Number
1
DI Record Publish Date
September 24, 2018
Package DI Number
50707387766325
Quantity per Package
8
Contains DI Package
30707387766321
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 274 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 444 |
| U | Unclassified | 7 |