Unipack

Basic Information

• Brand Name: Unipack
• Primary DI: D784UMA9113RO3
• Version / Model: UMA-9113-RO
• Catalog Number: UMA-9113-RO
• Company Name: UNIPACK MEDICAL CORPORATION
• Labeler DUNS: 018319397
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 400
• 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: c748f17d-b24d-4dcf-8f7d-4f6a402f1af0

Device Description

Micro Applicators Regular Orange/Peach

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
EJB	HANDLE, INSTRUMENT, DENTAL	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35697	Dental material application tool, single-use	A hand-held manual dental instrument intended to be used for the application of a dental restorative material (e.g., amalgam, resin) to a patient’s tooth/teeth; the restorative material is not included. It includes a handle with an application tip/brush which holds the material on its surface/bristles; it is not a syringe- or pistol-like 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	D784UMA9113RO5	HIBCC	Case	16	In Commercial Distribution
Primary	D784UMA9113RO3	HIBCC
Unit of Use	D784UMA9113RO0	HIBCC

Customer Contacts

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