DeScribe Transparent PFD Patch

GUDID 00186295000359

Individually packaged DeScribe PFD Patch (each)

MERZ NORTH AMERICA, INC.

Synthetic polymer semi-permeable film dressing, adhesive, non-sterile

• Primary Device ID: 00186295000359
• NIH Device Record Key: 9da66886-85f4-48ac-82b4-2f3382e03d97
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DeScribe Transparent PFD Patch
• Version Model Number: 5035837
• Company DUNS: 028147846
• Company Name: MERZ NORTH AMERICA, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 866-862-1211
• Email: mymerzsolutions@merz.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00186295000335 [Package]; Package: [10 Units]; In Commercial Distribution
GS1	00186295000359 [Primary]

FDA Product Code

• PKO: Transparent Patch For Use In Treatment Of Tattoos

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-02-06

On-Brand Devices [DeScribe Transparent PFD Patch]

• 00186295000366: Individually packaged DeScribe PFD Patch (each). Contains 2 Describe PFD Patches.
• 00186295000359: Individually packaged DeScribe PFD Patch (each)
• 00186295000342: Individually packaged DeScribe PFD Patch (each) Contains 5 DeScribe PFD Patches.