Genadur

Basic Information

• Brand Name: Genadur
• Primary DI: 00343538510123
• Version / Model: 2
• Company Name: Polichem SA, Lussemburgo, succursale di Mendrisio
• Labeler DUNS: 487972069
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-31
• Public Version: 2
• Public Version Date: 2020-08-07
• Public Version Status: Update
• Public Device Record Key: e773c6ef-19bd-4ce5-afcb-4e29b9eabf57

Device Description

Hydrosoluble Nail Lacquer is available in a 12 mL bottle with applicator brush.

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: No
• 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
KMF	Bandage, Liquid	General Hospital	880.5090	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62535	Skin-cover sealant	A biodegradable, synthetic (e.g., cyanoacrylate) substance intended to be applied over a superficial wound to set and form a barrier to reduce skin exposure to external contaminants. Sometimes referred to as a liquid bandage, it is intended for use in the home or a clinical setting and may be intended as an alternative to a conventional skin-cover adhesive strip. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00343538510123	GS1

Premarket Submissions

Submission Number	Supplement Number
K083087	000