Duns Number:830016148
Device Description: 3M(TM) Tegaderm(TM) HP (Holding Power) Transparent Film Dressing Frame Style 9519HP
Catalog Number
9519HP
Brand Name
3M™ Tegaderm™
Version/Model Number
9519HP
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
NAD
Product Code Name
Dressing, wound, occlusive
Public Device Record Key
c471ca80-16a0-4e19-846d-40b4608a573d
Public Version Date
December 22, 2021
Public Version Number
2
DI Record Publish Date
September 24, 2018
Package DI Number
50707387524628
Quantity per Package
4
Contains DI Package
04001895928819
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 |