Unipack

Basic Information

• Brand Name: Unipack
• Primary DI: 00850008682360
• Version / Model: UAT-9053
• Catalog Number: UAT-9053
• Company Name: UNIPACK MEDICAL CORPORATION
• Labeler DUNS: 018319397
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 250
• 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: e8bafb95-4bdb-46eb-872c-a960e976f12d

Device Description

COLOR-BRITE Air/Water Tips

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: Yes
• 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
EIB	Syringe, irrigating (dental)	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65430	Dental delivery system irrigation handpiece tip	A rigid, tubular device intended to be fitted to the distal end of a dental delivery system irrigation handpiece (not included) to direct a stream of pressurized, warmed water and/or air to the field of operation in the oral cavity to irrigate/clear debris during a restorative or operative dental procedure. This is a single use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10850008682367	GS1	Case	16	In Commercial Distribution
Primary	00850008682360	GS1
Unit of Use	20850008682364	GS1

Customer Contacts

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