Broken Screw Remocal

Basic Information

• Brand Name: Broken Screw Remocal
• Primary DI: B562HANPBS0
• Version / Model: HAN-PBS
• Company Name: Wishbone Medical, Inc.
• Labeler DUNS: 062355158
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-17
• Public Version: 4
• Public Version Date: 2023-04-03
• Public Version Status: Update
• Public Device Record Key: 129edb96-4b2b-4677-9a28-2374a3c62d9f
• Distribution End Date: 2023-03-16

Device Description

Broken Screw Removal T-Handle

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61029	Screw-extraction orthopaedic reamer, single-use	A surgical tool designed for overdrilling, gripping, and extracting an implanted surgical screw shaft when the screw head has become defective or detached, or the shaft has broken. It is in the form of a thin hollow metal shaft, with saw teeth at the cutting edge and a conical thread within the lumen. The device is rotated around the screw shaft to remove a thin layer of bone, either by a surgical power tool or a manual handle, until the internal thread grips the screw for removal. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B562HANPBS0	HIBCC