Genadur

GUDID 00343538510123

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

Polichem SA, Lussemburgo, succursale di Mendrisio

Skin-cover sealant

• Primary Device ID: 00343538510123
• NIH Device Record Key: e773c6ef-19bd-4ce5-afcb-4e29b9eabf57
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Genadur
• Version Model Number: 2
• Company DUNS: 487972069
• Company Name: Polichem SA, Lussemburgo, succursale di Mendrisio
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00343538510123 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083087

FDA Product Code

• KMF: Bandage, Liquid

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-08
• Device Publish Date: 2019-10-31