Accelstim

Basic Information

• Brand Name: Accelstim
• Primary DI: 08050040997336
• Version / Model: UBHS-02
• Catalog Number: 654300-9002
• Company Name: IGEA SPA
• Labeler DUNS: 429342710
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-04
• Public Version: 1
• Public Version Date: 2022-11-14
• Public Version Status: New
• Public Device Record Key: c27d537d-e7f1-462b-9c19-5d339cf21b8e

Device Description

Replacement Aquasonics 100 Ultrasound Gel, AccelStim 4300

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LOF	Stimulator, Bone Growth, Non-Invasive	Orthopedic	890.5870	2

GMDN Terms

Code	Name	Definition	Implantable	Status
18154	Bone growth ultrasonic stimulator	A mains electricity (AC-powered) device designed to accelerate bone formation (osteogenesis) through the application of ultrasound energy. It typically consists of a pulsed low-intensity ultrasound generator that includes a transducer probe and a retaining and alignment fixture for the probe. The device is typically used to promote healing of nonunion fractures; it is also used to speed the healing of fresh fractures.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08050040997336	GS1

Premarket Submissions

Submission Number	Supplement Number
P210035	000