FITBONE®

Basic Information

• Brand Name: FITBONE®
• Primary DI: 04260170144003
• Version / Model: Receiver
• Catalog Number: 60001615-00-0
• Company Name: WITTENSTEIN intens GmbH
• Labeler DUNS: 315887799
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-12-22
• Public Version: 6
• Public Version Date: 2023-09-18
• Public Version Status: Update
• Public Device Record Key: d7514c46-4456-4879-97bc-9c2aef4e4fed
• Distribution End Date: 2022-12-31

Device Description

Subcutaneous Energy Receiver

Device Characteristics

• Single Use: Yes
• 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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	888.3020	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63192	Long bone distraction nail receiver	An implantable electronic device designed to transmit energy to a motorized adjustable long bone rod (nail) from an external remote controller. The receiver is implanted into subcutaneous tissue, with a wired connection to the nail which is implanted during the same procedure into a long bone intermedullary cavity.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04260170144003	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]