Duns Number:830016148
Device Description: 3M™ Tegaderm™ Silicone Foam Border Dressing Heel/Elbow 5EA/CAR 4CAR/CS 90646
Catalog Number
90646
Brand Name
3M™ Tegaderm™
Version/Model Number
90646
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
NAC
Product Code Name
Dressing, wound, hydrophilic
Public Device Record Key
3a44f1f0-b628-4888-b058-a05a27b419d1
Public Version Date
June 22, 2021
Public Version Number
4
DI Record Publish Date
September 24, 2018
Package DI Number
50707387776805
Quantity per Package
4
Contains DI Package
00707387776800
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 |