AGILITY™

Basic Information

• Brand Name: AGILITY™
• Primary DI: 10190886052945
• Version / Model: AC1-205-X
• Company Name: G & H Wire Company, Inc.
• Labeler DUNS: 831465641
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2023-10-09
• Public Version: 1
• Public Version Date: 2023-10-17
• Public Version Status: New
• Public Device Record Key: 23673b46-85a9-424b-996b-3928db5d5740

Device Description

AGILITY BT-UR .022 WD COMB CONV ROTH -10°T 8°DO .045 HGO 10

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
DZD	Tube, Orthodontic	Dental	872.5410	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31759	Orthodontic tube	A device used in orthodontics to attach a wire(s) or headgear to orthodontic bands bonded to the teeth. It is typically welded to an orthodontic band or bonded to a tooth. This is a single-patient device that is 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
Unit of Use	00190886052948	GS1
Primary	10190886052945	GS1

Customer Contacts

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