1.5MM SYSTEM

Basic Information

• Brand Name: 1.5MM SYSTEM
• Primary DI: 00841036063504
• Version / Model: 50-1010
• Catalog Number: 50-1010
• Company Name: BIOMET MICROFIXATION, INC
• Labeler DUNS: 046189866
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-07
• Public Version: 1
• Public Version Date: 2018-10-08
• Public Version Status: New
• Public Device Record Key: fa51055d-3aed-4318-8556-fd9b69b128b3

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: 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GEY	MOTOR, SURGICAL INSTRUMENT, AC-POWERED	General, Plastic Surgery	878.4820	1

GMDN Terms

Code	Name	Definition	Implantable	Status
48058	Disposable battery pack	A group of battery cells (e.g., lithium ion cells) held within a container that is sterile used to provide temporary electrical energy to operate a medical device, typically when it is not possible, intentional, or convenient to connect the device being powered to a mains electricity (AC-powered) electrical outlet. This device is typically designed to power cordless surgical power tools (e.g., a non-rechargeable battery-powered surgical drilling system handpiece) and is non-rechargeable. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841036063504	GS1

Customer Contacts

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