Dr Yglo

GUDID 08720618589026

Dr Yglo Wart and Plantar Wart Remover

TheOTCLab B.V.

Wart-removal cryogenic kit

• Primary Device ID: 08720618589026
• NIH Device Record Key: d882d481-0b35-482d-8eee-1d2ad4e72e20
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dr Yglo
• Version Model Number: 1
• Company DUNS: 491870245
• Company Name: TheOTCLab B.V.
• Device Count: 1
• DM Exempt: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08720618589002 [Primary]
GS1	08720618589026 [Package]; Contains: 08720618589002; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210529

FDA Product Code

• GEH: Unit, Cryosurgical, Accessories

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: 2025-05-01
• Device Publish Date: 2025-04-23