Accelstim 654300-8002

GUDID 08050040997312

Replacement Transducer Holder, Accelstim 4300

IGEA SPA

Bone growth ultrasonic stimulator Bone growth ultrasonic stimulator Bone growth ultrasonic stimulator Bone growth ultrasonic stimulator Bone growth ultrasonic stimulator Bone growth ultrasonic stimulator Bone growth ultrasonic stimulator Bone growth ultrasonic stimulator Bone growth ultrasonic stimulator Bone growth ultrasonic stimulator Bone growth ultrasonic stimulator Bone growth ultrasonic stimulator Bone growth ultrasonic stimulator Bone growth ultrasonic stimulator

• Primary Device ID: 08050040997312
• NIH Device Record Key: 056a66a3-d045-49b2-8670-8b7a860b7291
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accelstim
• Version Model Number: UBHS-02
• Catalog Number: 654300-8002
• 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: 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	08050040997312 [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