Ulthera System Transducer

GUDID 00840763100865

ULTHERA, INC.

Ultrasound hyperthermia system transducer, extracorporeal

• Primary Device ID: 00840763100865
• NIH Device Record Key: ef8020af-f201-4ed8-a53d-8e452fe14579
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ulthera System Transducer
• Version Model Number: UT-1 Rev N
• Company DUNS: 010981554
• Company Name: ULTHERA, INC.
• 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: 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	00840763100865 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K134032

FDA Product Code

• OHV: Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-04-27

On-Brand Devices [Ulthera System Transducer]

• 00840763100896: UT-4N Rev L
• 00840763100889: UT-4 Rev L
• 00840763100865: UT-1 Rev N
• 00840763100858: UT-3 Rev N
• 00840763100841: UT-2 Rev O
• 00840763100834: UT-1N Rev N
• 00840763100360: UT-1N Rev. H
• 00840763100353: UT-3 Rev. H
• 00840763100346: UT-4 Rev. G
• 00840763100339: UT-2 Rev. J
• 00840763100322: UT-4N Rev. G
• 00840763100315: UT-1 Rev H
• 00840763100070: UT-4N Rev. F
• 00840763100063: UT-4 Rev. F
• 00840763100056: UT-3 Rev. G
• 00840763100049: UT-2 Rev. I
• 00840763100032: UT-1N Rev. G