Duns Number:830016148
Device Description: 3M™ Tegaderm™ + Pad Film Dressing with Non-Adherent Pad 3588
Catalog Number
3588
Brand Name
3M™ Tegaderm™
Version/Model Number
3588
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
2efc7914-5f36-41ce-aa14-a5a3006faf3d
Public Version Date
February 25, 2019
Public Version Number
2
DI Record Publish Date
September 24, 2018
Package DI Number
50707387472493
Quantity per Package
4
Contains DI Package
04001895928383
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 |