AccelStim 4300 Casting Kit Medium

GUDID 18257200158713

Casting Kit Assembly, Medium, Accessory, ACCELSTIM Model 4300

Orthofix US LLC

Bone growth ultrasonic stimulator

• Primary Device ID: 18257200158713
• NIH Device Record Key: 4169cbbb-991c-4cb3-aa36-c6d4d6f4a116
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AccelStim
• Version Model Number: 654300-9006
• Catalog Number: 4300 Casting Kit Medium
• Company DUNS: 927083808
• Company Name: Orthofix US LLC
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(214)937-2718
• Email: pemfcustomerservice@orthofix.com
• Phone: +1(214)937-2718
• Email: pemfcustomerservice@orthofix.com
• Phone: +1(214)937-2718
• Email: pemfcustomerservice@orthofix.com
• Phone: +1(214)937-2718
• Email: pemfcustomerservice@orthofix.com
• Phone: +1(214)937-2718
• Email: pemfcustomerservice@orthofix.com
• Phone: +1(214)937-2718
• Email: pemfcustomerservice@orthofix.com
• Phone: +1(214)937-2718
• Email: pemfcustomerservice@orthofix.com
• Phone: +1(214)937-2718
• Email: pemfcustomerservice@orthofix.com
• Phone: +1(214)937-2718
• Email: pemfcustomerservice@orthofix.com
• Phone: +1(214)937-2718
• Email: pemfcustomerservice@orthofix.com
• Phone: +1(214)937-2718
• Email: pemfcustomerservice@orthofix.com
• Phone: +1(214)937-2718
• Email: pemfcustomerservice@orthofix.com
• Phone: +1(214)937-2718
• Email: pemfcustomerservice@orthofix.com
• Phone: +1(214)937-2718
• Email: pemfcustomerservice@orthofix.com
• Phone: +1(214)937-2718
• Email: pemfcustomerservice@orthofix.com
• Phone: +1(214)937-2718
• Email: pemfcustomerservice@orthofix.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	18257200158713 [Primary]

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: 2023-06-20
• Device Publish Date: 2023-06-12

On-Brand Devices [AccelStim]

• 18257200158720: Casting Kit Assembly, Large, Accessory, ACCELSTIM Model 4300
• 18257200158713: Casting Kit Assembly, Medium, Accessory, ACCELSTIM Model 4300
• 18257200158706: Casting Kit Assembly, Small, Accessory, ACCELSTIM Model 4300