2mm AdvanSync Spacer, Pk/2

Basic Information

• Brand Name: 2mm AdvanSync Spacer, Pk/2
• Primary DI: 00889989083293
• Version / Model: MATER210
• Company Name: ALLESEE AOA-PRO
• Labeler DUNS: 158312728
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2022-12-14
• Public Version: 1
• Public Version Date: 2022-12-22
• Public Version Status: New
• Public Device Record Key: 8b691918-6859-46b3-965a-64893a625fa4

Device Description

2mm AdvanSync Spacer, Pk/2

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
EJF	BRACKET, METAL, ORTHODONTIC	Dental	872.5410	1

GMDN Terms

Code	Name	Definition	Implantable	Status
40734	Orthodontic clasp, metal, custom-made	A dental device made of cast metal material intended to retain and stabilize a removable orthodontic appliance to stationary teeth. It is manufactured to meet the specifications of an individual patient. 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	10889989083290	GS1
Primary	00889989083293	GS1

Customer Contacts

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