DEVICE: DeScribe Transparent PFD Patch (00186295000359)
Device Identifier (DI) Information
DeScribe Transparent PFD Patch
5035837
In Commercial Distribution
MERZ NORTH AMERICA, INC.
5035837
In Commercial Distribution
MERZ NORTH AMERICA, INC.
Individually packaged DeScribe PFD Patch (each)
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
58300 | Synthetic polymer semi-permeable film dressing, adhesive, non-sterile |
A non-sterile, transparent, semi-permeable (i.e., impermeable to fluids, permeable to vapours and gases) covering applied to skin typically intended to fix a primary dressing or a medical device (e.g. drainage tube), or to provide protection from fluids. It is a thin, clear film made of synthetic polymer material that is covered on one side with a pressure-sensitive adhesive. This is a single-use device.
|
Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
PKO | Transparent Patch For Use In Treatment Of Tattoos |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
9da66886-85f4-48ac-82b4-2f3382e03d97
March 29, 2018
2
February 06, 2017
March 29, 2018
2
February 06, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
00186295000335 | 10 | 00186295000359 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
866-862-1211
mymerzsolutions@merz.com
mymerzsolutions@merz.com