Pinnacle Temple Guard

Basic Information

• Brand Name: Pinnacle Temple Guard
• Primary DI: 00615375004715
• Version / Model: 7300C
• Company Name: METREX RESEARCH, LLC
• Labeler DUNS: 145963778
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 200
• Record Status: Published
• Publish Date: 2016-08-31
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: c5742b47-3756-4456-9027-d05388613fa7

Device Description

Panoramic HeadPositioning Guide Cover

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: No
• 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MMP	Cover, barrier, protective	General, Plastic Surgery	878.4370	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58094	Headrest cover	A non-sterile device designed as an outer covering and used for the protection of a headrest against unhygienic conditions and helps prevent the occurrence of gross soiling. It will typically be made of thin, shaped, plastic/textile material which creates a physical barrier between the patient's head and the head supporting device. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	D68373001	HIBCC
Primary	00615375004715	GS1
Unit of Use	00615375007471	GS1

Customer Contacts

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