Duns Number:830016148
Device Description: 3M(TM) Tegaderm(TM) Transparent Film Roll 16006
Catalog Number
16006
Brand Name
3M™ Tegaderm™
Version/Model Number
16006
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
KGX
Product Code Name
Tape and bandage, adhesive
Public Device Record Key
35a886d5-f89e-4291-bfbf-0c9f4f90c036
Public Version Date
October 25, 2018
Public Version Number
1
DI Record Publish Date
September 24, 2018
Package DI Number
50707387565416
Quantity per Package
4
Contains DI Package
00707387565411
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 |