RZ Medizintechnik GmbH

Basic Information

• Brand Name: RZ Medizintechnik GmbH
• Primary DI: 04049197471497
• Version / Model: 410-142-135
• Catalog Number: 410-142-135
• Company Name: RZ-Medizintechnik GmbH
• Labeler DUNS: 312953227
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-06-28
• Public Version: 1
• Public Version Date: 2024-07-08
• Public Version Status: New
• Public Device Record Key: bea75355-2e63-45a1-ab5e-05c56d4dd958

Device Description

AUSTIN Measuring probe (caliper) determe length of stapes prosthesis, 6 1/4" markings at 3.5mm

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: Yes
• 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: 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
KAK	PROBE, ENT	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64971	General surgery wound probe/packer	A slender, double-ended, hand-held manual surgical instrument intended to be used to explore and examine wounds, and additionally to introduce and pack gauze or dressings into the wound. It consists of a flat blunt blade at one end and a packer at the other end, with the handle formed from its middle section; it is made of metallic and/or synthetic polymer material. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04049197471497	GS1

Customer Contacts

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