THERMAGE FLX TF-3

GUDID 00816995026341

COUPLING GEL, 60G

SOLTA MEDICAL

Radio-frequency skin contouring system

• Primary Device ID: 00816995026341
• NIH Device Record Key: 0b835d10-95f6-4528-b7fc-bea7975e6486
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: THERMAGE FLX
• Version Model Number: TF-3
• Catalog Number: TF-3
• Company DUNS: 079999584
• Company Name: SOLTA MEDICAL
• 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: 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	00816995026341 [Primary]

FDA Product Code

• ISA: Massager, Therapeutic, Electric

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-05
• Device Publish Date: 2017-12-14

On-Brand Devices [THERMAGE FLX]

• 00816995027041: Thermage FLX System, Refurbished
• 00816995027034: Thermage FLX Handpiece, Refurbished
• 00816995026914: LARGE, GRID, SKIN MARKING, 4.00 SQUARE CM
• 00816995026341: COUPLING GEL, 60G
• 00816995021445: FOOTSWITCH
• 00816995021438: FLX TREATMENT TIP, TOTAL, 4.0CM2, 900 REP
• 00816995021421: FLX TREATMENT TIP, TOTAL, 4.0CM2, 600 REP
• 00816995021414: FLX TREATMENT TIP, TOTAL, 4.0CM2, 300 REP
• 00816995021407: FLX TREATMENT TIP, TOTAL, 3.0CM2, 900 REP
• 00816995021391: FLX TREATMENT TIP, TOTAL, 3.0CM2, 600 REP
• 00816995021384: FLX TREATMENT TIP, TOTAL, 3.0CM2, 400 REP
• 00816995021377: FLX TREATMENT TIP, TOTAL, 3.0CM2, 1200 REP
• 00816995021360: FLX TREATMENT TIP, BODY, 16.0CM2, 1200 REP
• 00816995021353: FLX TREATMENT TIP, EYE, 0.25CM2, 450 REP
• 00816995021346: FLX TREATMENT TIP, EYE, 0.25CM2, 225 REP
• 00816995021339: GRID, SKIN MARKING, 16.00 SQUARE CM
• 00816995021322: GRID, SKIN MARKING, 4.00 SQUARE CM
• 00816995021315: LARGE, GRID, SKIN MARKING, 3.00 SQUARE CM
• 00816995021308: THERMAGE FLX SKIN MARKING GRID (3.00 CM2)
• 00816995021292: THERMAGE FLX SKIN MARKING GRID (0.25 CM2)
• 00816995021285: THERMAGE FLX PATIENT RETURN PAD
• 00816995021278: THERMAGE FLX HANDPIECE
• 00816995020639: Thermage FLX RF System