Accelstim 654300-9001

GUDID 08050040997299

Replacement Ultrasound Gel, Accelstim 4300

IGEA SPA

Bone growth ultrasonic stimulator

• Primary Device ID: 08050040997299
• NIH Device Record Key: dc93e8ed-0421-45ae-b130-72b561517b40
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accelstim
• Version Model Number: UBHS-02
• Catalog Number: 654300-9001
• Company DUNS: 429342710
• Company Name: IGEA SPA
• 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: true
• Serial Number: false
• Manufacturing Date: false
• 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	08050040997299 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P210035

FDA Product Code

• LOF: Stimulator, Bone Growth, Non-Invasive

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: 2022-09-07
• Device Publish Date: 2022-08-30

On-Brand Devices [Accelstim]

• 08050040997213: Bone Growth Stimulator
• 08050040997329: Replacement Power Supply, Accelstim 4300
• 08050040997312: Replacement Transducer Holder, Accelstim 4300
• 08050040997305: Replacement Strap, Accelstim 4300
• 08050040997299: Replacement Ultrasound Gel, Accelstim 4300
• 08050040997336: Replacement Aquasonics 100 Ultrasound Gel, AccelStim 4300