Duns Number:830016148
Device Description: 90501 TEGADERM SILVER NONWOVEN DRESSING, 4X5IN 5EA/BX, 4 BX/CS
Catalog Number
90501
Brand Name
Tegaderm™
Version/Model Number
90501
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K053256,K053256,K053256
Product Code
FRO
Product Code Name
Dressing, wound, drug
Public Device Record Key
3806420b-e2d4-4158-9d13-049a5849091b
Public Version Date
May 06, 2021
Public Version Number
4
DI Record Publish Date
October 13, 2016
Package DI Number
50707387565317
Quantity per Package
4
Contains DI Package
30707387565313
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 |