Main-Knife - Alphatec

Basic Information

• Brand Name: Main-Knife - Alphatec
• Primary DI: B9081600060
• Version / Model: 471-25-901
• Catalog Number: 1600-06
• Company Name: Mainstream Medical Devices, LLC
• Labeler DUNS: 071513432
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-03-02
• Public Version: 1
• Public Version Date: 2024-03-11
• Public Version Status: New
• Public Device Record Key: 04432143-d513-41f6-a270-8424dc222968

Device Description

Single Piece Annulotomy Knife, Sterile

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: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EMF	Knife, Surgical	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47569	Scalpel, single-use	A hand-held, manual surgical instrument constructed as a one-piece handle and scalpel blade (not an exchangeable component) used by the operator to manually cut or dissect tissue. The blade is typically made of high-grade stainless steel alloy or carbon steel and the handle is often made of plastic. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B9081600060	HIBCC