NA

Basic Information

• Brand Name: NA
• Primary DI: 04048551400524
• Version / Model: 28164MC-S
• Catalog Number: 28164MC-S
• Company Name: Karl Storz GmbH & Co. KG
• Labeler DUNS: 315731430
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 3
• Record Status: Published
• Publish Date: 2025-03-28
• Public Version: 1
• Public Version Date: 2025-04-07
• Public Version Status: New
• Public Device Record Key: c80d0b3c-ffba-4b9e-8df1-f62bb24e860f

Device Description

MICRO KNIFE, POINTED, FOR 28164M,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: 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
HAO	INSTRUMENT, SURGICAL, NON-POWERED	Neurology	882.4535	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35141	Scalpel, reusable	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 device is typically made of high-grade stainless steel alloy. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	04048551400531	GS1
Primary	04048551400524	GS1

Customer Contacts

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