Duns Number:830016148
Device Description: 3M™ Cavilon™ No Sting Barrier Film, 3344E, 1ML Wipe, 30 Each/Carton, 6 Cartons/Case
Catalog Number
3344E
Brand Name
3M™ Cavilon™
Version/Model Number
3344E
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
9805dd26-af65-43f0-b961-b4fe3b6210d3
Public Version Date
May 31, 2021
Public Version Number
1
DI Record Publish Date
May 21, 2021
Package DI Number
50707387791884
Quantity per Package
6
Contains DI Package
30707387791880
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 |