DeScribe Transparent PFD Patch

Basic Information

• Brand Name: DeScribe Transparent PFD Patch
• Primary DI: 00186295000359
• Version / Model: 5035837
• 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: 9da66886-85f4-48ac-82b4-2f3382e03d97

Device Description

Individually packaged DeScribe PFD Patch (each)

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	00186295000359	GS1
Package	00186295000335	GS1		10	In Commercial Distribution

Customer Contacts

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