Duns Number:830016148
Device Description: 3M™ Tegaderm™ CHG Dressing 25/Carton 4 Cartons/Case 1657
Catalog Number
1657
Brand Name
Tegaderm™
Version/Model Number
1657
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
-
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
9d01afd3-7bcd-48f4-9025-142b9b1e0533
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 30, 2016
Package DI Number
50707387578317
Quantity per Package
4
Contains DI Package
30707387578313
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 |