ELITE MEDICAL INSTRUMENTATION

Basic Information

• Brand Name: ELITE MEDICAL INSTRUMENTATION
• Primary DI: G569EMIBV075R0
• Version / Model: EMI-BV075R
• Catalog Number: EMI-BV075R RETRACTOR
• Company Name: ELITE MEDICAL INSTRUMENTATION
• Labeler DUNS: 116733674
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-03-21
• Public Version: 1
• Public Version Date: 2024-03-29
• Public Version Status: New
• Public Device Record Key: 50b7c32c-6086-49d4-8171-400f7bb92e53

Device Description

Retractor, Weitlaner, 3x4 Prong, Blunt, 165mm, 6 1/2"

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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• 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
EIG	Retractor, All Types	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
33542	Bone hook	A hand-held, surgical instrument used for hooking around or into bone, typically to grasp, hold, and apply traction to the bone during a surgical intervention. It is a shaft-like instrument with a robust design and can have a singular hook or multiple hooks at the distal end and a handle of various designs at the proximal end. It is made of high-grade stainless steel. It is sometimes called a bone retractor. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	G569EMIBV075R0	HIBCC

Device Sizes

Type	Value	Unit	Text
Length	6.5	Inch