Pinnacle Cure Sleeve

Basic Information

• Brand Name: Pinnacle Cure Sleeve
• Primary DI: 00615375004654
• Version / Model: 4513C
• Company Name: METREX RESEARCH, LLC
• Labeler DUNS: 145963778
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 400
• 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: 10e5e703-640b-41f9-a138-4c83ff7a59a8

Device Description

Curing Light Tip Sleeves Fits 13mm Tips

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
33878	Cable/lead/sensor/probe cover, non-sterile	A non-sterile device, typically made of disposable plastic, that forms a protective enclosure around its cable/lead, probe, sensor, or tube contents, making a hygienic barrier to protect the contents from soiling and contamination so that the non-sterile contents may be used in the vicinity of, or enter into a hygienic area, e.g., a sterile surgical field. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	D68345131	HIBCC
Primary	00615375004654	GS1
Unit of Use	00615375007457	GS1

Customer Contacts

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