Duns Number:028147846
Device Description: Individually packaged DeScribe PFD Patch (each)
Catalog Number
-
Brand Name
DeScribe Transparent PFD Patch
Version/Model Number
5035837
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
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
PKO
Product Code Name
Transparent Patch For Use In Treatment Of Tattoos
Public Device Record Key
9da66886-85f4-48ac-82b4-2f3382e03d97
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
February 06, 2017
Package DI Number
00186295000335
Quantity per Package
10
Contains DI Package
00186295000359
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |
| 3 | A medical device with high risk that requires premarket approval | 8 |