Single Use Surgical Professional

Basic Information

• Brand Name: Single Use Surgical Professional
• Primary DI: 05055299102176
• Version / Model: S125
• Catalog Number: S125
• Company Name: EAKIN SURGICAL LIMITED
• Labeler DUNS: 239505063
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-19
• Public Version: 5
• Public Version Date: 2024-02-19
• Public Version Status: Update
• Public Device Record Key: bc244f94-a670-4be1-997e-5cff9e5ba571

Device Description

Kerrison Rongeur 1mm x 200mm 45°contains 6 units

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: Yes
• 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
HTX	Rongeur	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64336	Bone-coring punch, single-use	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 single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05055299102176	GS1
Package	05055299102183	GS1	Carton	6	In Commercial Distribution

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	200	Millimeter
Angle	45	degree
Device Size Text, specify			Bite Size 1mm