Unipack

Basic Information

• Brand Name: Unipack
• Primary DI: D784UBC8013F1
• Version / Model: UBC-8013F
• Catalog Number: UBC-8013F
• Company Name: UNIPACK MEDICAL CORPORATION
• Labeler DUNS: 018319397
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 500
• Record Status: Published
• Publish Date: 2022-12-07
• Public Version: 1
• Public Version Date: 2022-12-15
• Public Version Status: New
• Public Device Record Key: 9297781e-dd44-4940-b379-9fde669c71f6

Device Description

Tray Sleeves F-Tray 7 1/2" x 10 1/2"

Device Characteristics

• Single Use: Yes
• 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
NRD	Unit, operative dental, accessories	Dental	872.6640	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64367	Instrument tray cover, single-use	A flexible, synthetic polymer cover designed to be placed on an instrument tray to provide a protective barrier for the transport and short-term storage of clinical instruments (typically endoscopes or surgical instruments). It is typically available in two colours to indicate clean/sterile or contaminated; a tray liner is typically supplied with the device. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	D784UBC8013F5	HIBCC	Case	12	In Commercial Distribution
Primary	D784UBC8013F1	HIBCC
Unit of Use	D784UBC8013F0	HIBCC

Customer Contacts

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