GUBISCH CARTILAGE CRUSHER

Basic Information

• Brand Name: GUBISCH CARTILAGE CRUSHER
• Primary DI: 00192896032064
• Version / Model: 350-851
• Catalog Number: 350-851
• Company Name: SONTEC INSTRUMENTS, INC.
• Labeler DUNS: 040729840
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-17
• Public Version: 3
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 958a0356-dc4f-44b9-a1d7-99634a688140

Device Description

GUBISCH CARTILAGE CRUSHER

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: ["Moist Heat or Steam Sterilization", "Dry Heat Sterilization"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HWN	INSTRUMENT, COMPRESSION	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62924	Surgical tissue compression device	A manual compression device designed to flatten, compact, or sculpt implantable tissues and tissue reconstructive materials (e.g., bone, cartilage, bone/fascia graft, gel foam) prior to their use in a surgical procedure. It may be referred to as a tissue crusher and is typically in the form of two hinged plates with a tightening mechanism (e.g., screws) to press the plates together with the material between, or a pliers-like device with jaws that compress. It is typically made of metal. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00192896032064	GS1

Customer Contacts

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