NUERA TIGHT

GUDID 08052049500104

BIOS SRL

Radio-frequency skin contouring system

• Primary Device ID: 08052049500104
• NIH Device Record Key: 0407b924-3185-4e92-8192-b97cd0fdbcbb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NUERA TIGHT
• Version Model Number: APMD140
• Company DUNS: 443571203
• Company Name: BIOS SRL
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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	08052049500104 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151296

FDA Product Code

• PBX: Massager, Vacuum, Radio Frequency Induced Heat

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: 2019-05-14
• Device Publish Date: 2019-05-06

On-Brand Devices [NUERA TIGHT]

• 08052049500104: APMD140
• 08052049500111: APMD145-1ch.US