accessory

Basic Information

• Brand Name: accessory
• Primary DI: E4942186071
• Version / Model: Pours button standard/ pair
• Catalog Number: 218607
• Company Name: Amann Girrbach AG
• Labeler DUNS: 300708950
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-07
• Public Version: 1
• Public Version Date: 2022-09-15
• Public Version Status: New
• Public Device Record Key: 736720d5-6c16-4f0a-81f2-4467f642bac3

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: No
• PM Exempt: Yes
• Has Serial Number: Yes
• 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
KCR	Facebow	Dental	872.3220	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	E4942186071	HIBCC

Customer Contacts

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