Stainless Steel

Basic Information

• Brand Name: Stainless Steel
• Primary DI: D78866021100151
• Version / Model: 66-0211-0015
• Catalog Number: 66-0211-0015
• Company Name: Gc Orthodontics America Inc.
• Labeler DUNS: 063167128
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2021-08-23
• Public Version: 1
• Public Version Date: 2021-08-31
• Public Version Status: New
• Public Device Record Key: 28bc72bf-f5dc-40f4-87c1-c634a8228fdb

Device Description

Surgical Ball Hook .018 Pack of 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: 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
ECN	CLAMP, WIRE, ORTHODONTIC	Dental	872.5410	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63379	Orthodontic power arm/lock	An orthodontic device in the shape of a straight pin or hook designed to accept an elastic band, power chain, spring, or archwire (not included), which apply a force in addition to the main orthodontic archwire, for vertical alignment and/or horizontal positioning of the teeth; it also includes a base that functions as an orthodontic lock/stop. The device is crimped, soldered or screwed on an orthodontic attachment (e.g., bracket, archwire) or the surface of a tooth. This is a single-patient device intended to be used for the duration of treatment (single-use) before being discarded.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	D78866021100150	HIBCC
Primary	D78866021100151	HIBCC

Customer Contacts

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