NOIR

Basic Information

• Brand Name: NOIR
• Primary DI: 04046964508752
• Version / Model: FK921B
• Catalog Number: FK921B
• Company Name: Aesculap AG
• Labeler DUNS: 315018218
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-06-17
• Public Version: 3
• Public Version Date: 2021-10-19
• Public Version Status: Update
• Public Device Record Key: c8c4c7cf-2871-4c43-8356-39243225cdb5

Device Description

KERRISON NOIR Bone Punch conventional, 130 °, upwards cutting, 9", (230 mm), width: 4 mm, opening width: 12 mm, detachable, with ejector, standard, non-sterile, reusable, to be used with: JF120R

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

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LRY	PUNCH, SURGICAL	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64337	Bone-coring punch, reusable	A hand-held manual surgical instrument designed to cut out (core) sections of bone, or a combination of bone and soft-tissue, during surgery. It consists of a handle and a cylindrical distal tip which has a bevelled, sharp cutting edge, which when cored into the bone and gently rotated will penetrate and cut through the bone allowing that section to be removed. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04046964508752	GS1

Customer Contacts

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