Duns Number:830016148
Device Description: 3M™ Tegaderm™ Transparent Film Dressing Frame Style 1624W, 2 3/8 IN x 2-3/4 IN, 100 DRSG/C 3M™ Tegaderm™ Transparent Film Dressing Frame Style 1624W, 2 3/8 IN x 2-3/4 IN, 100 DRSG/CTN, 4 CTN/CS
Catalog Number
1624W
Brand Name
3M™ Tegaderm™
Version/Model Number
1624W
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
-
Product Code
NAD
Product Code Name
Dressing, wound, occlusive
Public Device Record Key
ada5eae7-2e2f-46a3-b961-9d9df827b785
Public Version Date
December 22, 2021
Public Version Number
2
DI Record Publish Date
October 16, 2020
Package DI Number
50707387787344
Quantity per Package
4
Contains DI Package
30707387787340
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| 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 |