KOHDENT

Basic Information

• Brand Name: KOHDENT
• Primary DI: 04251436926044
• Version / Model: 7567
• Catalog Number: 7567
• Company Name: Kohdent Roland Kohler Medizintechnik GmbH & Co. KG
• Labeler DUNS: 324006097
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-08-30
• Public Version: 1
• Public Version Date: 2021-09-07
• Public Version Status: New
• Public Device Record Key: 6a576c3b-f8a6-412d-9eea-a3ade1c8b0e5

Device Description

Measuring caliper according Dr.Siewert flexible, 8-10-12-14-16-18 with TRINOVO handle

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
FTY	TAPE, MEASURING, RULERS AND CALIPERS	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35700	Facebow	A caliper-like dynamic dental instrument intended for use in a dental diagnostic procedure to record the relative position of the mandible to the temporomandibular joints (TMJs) and/or to record the spatial relationship between the maxilla and mandible. This determination is intended for use in placing models of the upper and lower jaws into an articulator and/or in assessing a range of movements in the TMJs. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04251436926044	GS1

Customer Contacts

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