Duns Number:830016148
Device Description: 3M™ Tegaderm™ CHG Chlorhexidine Gluconate Gel Pad 1664, 25 each/carton, 4 cartons/case
Catalog Number
1664
Brand Name
3M™ Tegaderm™
Version/Model Number
1664
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
b16c4b7f-997d-48d2-af79-9a89247cbcca
Public Version Date
November 06, 2020
Public Version Number
2
DI Record Publish Date
October 16, 2020
Package DI Number
50707387791396
Quantity per Package
4
Contains DI Package
30707387791392
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 |