Unipack

Basic Information

• Brand Name: Unipack
• Primary DI: D784UBC85508S1
• Version / Model: UBC-85508S
• Catalog Number: UBC-85508S
• Company Name: UNIPACK MEDICAL CORPORATION
• Labeler DUNS: 018319397
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 72
• Record Status: Published
• Publish Date: 2022-12-06
• Public Version: 1
• Public Version Date: 2022-12-14
• Public Version Status: New
• Public Device Record Key: ff965d71-766d-4d15-aec2-fa785237185c

Device Description

Saliva Ejector Screens 85508S Universal Fit

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: 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
EHZ	Evacuator, oral cavity	Dental	872.6640	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65060	Dental suction system in-line filter	A screening device designed to be fitted in the suction line of a dental suction system (e.g., in the saliva ejector valve) to trap debris [e.g., amalgam, bone particles, dentin/enamel particles] and stop them from entering the mains drainage system during a dental procedure. It is in the form of cylindrical/conical flange with numerous small openings. The device is not intended to be used as a dedicated autologous bone particle collector. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	D784UBC85508S5	HIBCC	Case	50	In Commercial Distribution
Primary	D784UBC85508S1	HIBCC
Unit of Use	D784UBC85508S0	HIBCC

Customer Contacts

• Phone: [phone] ext. 172
• Email: [email protected]