Pinnacle Headrest Cover

Basic Information

• Brand Name: Pinnacle Headrest Cover
• Primary DI: 00615375004500
• Version / Model: 3511C
• Company Name: METREX RESEARCH, LLC
• Labeler DUNS: 145963778
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 250
• 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: a089b8ed-6599-472a-b8f7-eae6c82dce69

Device Description

Patient Chair Headrest Sleeves

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	D68335111	HIBCC
Primary	00615375004500	GS1
Unit of Use	00615375007303	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Dimension 11 x 9.5