Life Instruments

Basic Information

• Brand Name: Life Instruments
• Primary DI: M930725102400
• Version / Model: 725-1024-0
• Company Name: Life Instrument Corporation
• Labeler DUNS: 948025002
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-05-28
• Public Version: 2
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: c79e74c4-d70f-4717-93ba-1f1117bd062a

Device Description

Double Ended Penfield Custom

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: 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
HTE	Elevator	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35048	Bone lever/elevator, reusable	A manual surgical instrument designed to lift, position, or pry up (elevate) bone, other anatomical structures, or surgical material/devices during an orthopaedic intervention. It is made of high-grade stainless steel and is available in a wide variety of sizes, designs, and blade shapes. It is typically a robust instrument with a blunted blade with no cutting edge at the distal end that can be pointed, rounded, flat, curved or hook shaped and a handle of various designs at the proximal end. Some types can have special functions, e.g., for angle joint operations or for luxation procedures. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M930725102400	HIBCC