NA

Basic Information

• Brand Name: NA
• Primary DI: 10190886101643
• Version / Model: 500-001
• Company Name: G & H Wire Company, Inc.
• Labeler DUNS: 831465641
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 960
• Record Status: Published
• Publish Date: 2025-03-26
• Public Version: 1
• Public Version Date: 2025-04-03
• Public Version Status: New
• Public Device Record Key: 7b40b18f-ff8f-4a2e-a63e-5eef14bd7810

Device Description

MOLDED BLUE SEPARATORS

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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ECI	Band, elastic, orthodontic	Dental	872.5410	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63708	Orthodontic separator	A non-surgical orthodontic device typically in the form of a loop or ring intended to be placed between adjacent teeth to slowly move them apart to help achieve improved positioning and/or appearance of the teeth; it is not intended for separation of tooth roots. 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
Unit of Use	00190886101646	GS1
Primary	10190886101643	GS1

Customer Contacts

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