APC™ II Unitek™ Gemini

Basic Information

• Brand Name: APC™ II Unitek™ Gemini
• Primary DI: 00652221068255
• Version / Model: 3119-755
• Catalog Number: 3119-755
• Company Name: 3M UNITEK CORPORATION
• Labeler DUNS: 008256356
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2017-08-04
• Public Version: 4
• Public Version Date: 2021-11-01
• Public Version Status: Update
• Public Device Record Key: 5b646444-2922-4350-884b-14799d67c078

Device Description

Unitek(TM) Gemini Bracket APC(TM) II Roth L4 -17T/0A .022 5/Pk

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DYH	ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN	Dental	872.3750	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46581	Orthodontic bracket, metal	A metallic device that is bonded to an orthodontic band, or directly to a tooth, to hold an orthodontic wire and/or other appliance (e.g., rubber bands) used to apply pressure to the tooth in order to alter the position of the tooth. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00652221068255	GS1
Unit of Use	80652221068251	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]