Mastel Precision Surgical Instruments, Inc.

Basic Information

• Brand Name: Mastel Precision Surgical Instruments, Inc.
• Primary DI: 00642356100104
• Version / Model: 10.301.2010
• Catalog Number: 10.301.2010
• Company Name: Mastel Precision Surgical Instruments, Inc.
• Labeler DUNS: 789897865
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-08-15
• Public Version: 1
• Public Version Date: 2022-08-23
• Public Version Status: New
• Public Device Record Key: d7aa9698-839b-4908-ad1a-01527e78b6d8

Device Description

President Stegmann Katana, Straight Mount

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: Yes
• 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
HNN	Knife, Ophthalmic	Ophthalmic	886.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32764	Ophthalmic knife, reusable	A hand-held manual ophthalmic surgical instrument designed to make precise incisions in the eye and surrounding tissues during ophthalmic surgery. It is typically designed as a one-piece instrument with a sharp, single-edged cutting blade at the distal tip and a handle at the proximal end. It can have a variety of blade edge shapes, e.g., phaco (blunt or sharp), crescent, straight, and micro-phaco (for micro incision cataract surgery). It is usually made of high-grade stainless steel and some types can employ diamond blades. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00642356100104	GS1

Customer Contacts

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