Duns Number:830016148
Device Description: 3M™ Tegaderm™ Antimicrobial Transparent Dressing 2-3/8INx2-3/4IN 400DSG/CS 9124
Catalog Number
9124
Brand Name
3M™ Tegaderm™
Version/Model Number
9124
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K170754,K170754,K170754
Product Code
FRO
Product Code Name
Dressing, wound, drug
Public Device Record Key
ba391c78-6c2b-4054-b3f3-0cca842241da
Public Version Date
October 05, 2018
Public Version Number
1
DI Record Publish Date
September 04, 2018
Package DI Number
50707387785845
Quantity per Package
4
Contains DI Package
30707387785841
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 |