Unipack

Basic Information

• Brand Name: Unipack
• Primary DI: D784UBC855001
• Version / Model: UBC-85500
• Catalog Number: UBC-85500
• Company Name: UNIPACK MEDICAL CORPORATION
• Labeler DUNS: 018319397
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 144
• 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: 55dc5c65-2319-4e2c-8993-7d28e6980221

Device Description

Evacuation Traps 85500 Diameter 1-1/4"

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	D784UBC855005	HIBCC	Case	8	In Commercial Distribution
Primary	D784UBC855001	HIBCC
Unit of Use	D784UBC855000	HIBCC

Customer Contacts

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