NA

Basic Information

• Brand Name: NA
• Primary DI: 00849771032861
• Version / Model: Twist Drill Rack
• Catalog Number: KI05RACKTD
• Company Name: KEY SURGICAL, INC.
• Labeler DUNS: 604056226
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-04-03
• Public Version: 1
• Public Version Date: 2023-04-11
• Public Version Status: New
• Public Device Record Key: 6ddb97ce-1eb9-42e3-ad69-44e6a9d25083

Device Description

Twist Drill Rack Holds up to 13 drill bits 5-inch in length

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FSM	TRAY, SURGICAL, INSTRUMENT	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61918	Orthopaedic bone pin container	A non-sterile cylindrical device intended to temporarily hold one or more orthopaedic pin(s) [e.g., K-wires] during sterilization and a surgical procedure for protection against damage. It is made of metal (e.g., stainless steel) and is typically a cylinder with a screw top, with lateral fenestrations to enable the penetration of sterilization fluid. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00849771032861	GS1

Customer Contacts

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