Health-Tec Ultra Digital X-Ray Sensor Sheaths

Basic Information

• Brand Name: Health-Tec Ultra Digital X-Ray Sensor Sheaths
• Primary DI: D773660925001
• Version / Model: 660-92500
• Catalog Number: 660-92500
• Company Name: Dental Health Products Inc
• Labeler DUNS: 623191194
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 500
• Record Status: Published
• Publish Date: 2017-01-17
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: c0add8eb-9cb7-4ec0-83ed-caff5e2166e4

Device Description

Health-Tec Ultra Digital X-Ray Sensor Sheaths, Size 2

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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
PEM	Dental Barriers And Sleeves	General, Plastic Surgery	878.4370	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61050	Dental bib	A non-sterile device intended to be worn by a patient during a dental examination or treatment procedure to function as a barrier to soiling and cross-contamination. It typically consists of a shaped piece of natural and/or synthetic material intended to be fastened around the neck and cover the front side of the upper body. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D773660925001	HIBCC
Unit of Use	D773660925000	HIBCC
Package	D773660925003	HIBCC		20	In Commercial Distribution

Customer Contacts

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