n/a

Basic Information

• Brand Name: n/a
• Primary DI: E0HMBKA031
• Version / Model: BKA03
• Catalog Number: BKA03
• Company Name: Hager & Meisinger Gesellschaft mit beschränkter Haftung
• Labeler DUNS: 318034329
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-09-15
• Public Version: 1
• Public Version Date: 2021-09-23
• Public Version Status: New
• Public Device Record Key: 53d665ec-2926-4038-a302-509c18b18e1a

Device Description

Rotary instrument for surgical application

Device Characteristics

• Single Use: No
• 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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
EJL	BUR, DENTAL	Dental	872.3240	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64304	Manual non-rotary dental instrument handle	A hand-held, manual device designed to hold and facilitate manipulation of a non-powered, non-rotary dental instrument (e.g., endodontic file/rasp, implant extractor). It is designed to accept the patient-contact endpiece (not included) for ease of handling. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	E0HMBKA031	HIBCC

Customer Contacts

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