DeScribe Transparent PFD Patch

Basic Information

• Brand Name: DeScribe Transparent PFD Patch
• Primary DI: 00186295000342
• Version / Model: 5035838
• Company Name: MERZ NORTH AMERICA, INC.
• Labeler DUNS: 028147846
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-06
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: ecda83d8-4c06-431e-a9a2-b7348eeb20c9

Device Description

Individually packaged DeScribe PFD Patch (each) Contains 5 DeScribe PFD Patches.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PKO	Transparent Patch For Use In Treatment Of Tattoos	General, Plastic Surgery	878.4810	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00186295000342	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]