11X KLO Metal Self-Ligating -15.2

Basic Information

• Brand Name: 11X KLO Metal Self-Ligating -15.2
• Primary DI: 06970469418606
• Version / Model: BR11X-V
• Company Name: Zhejiang Headway Medical Equipment Co., Ltd
• Labeler DUNS: 412892520
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-11-26
• Public Version: 1
• Public Version Date: 2025-12-04
• Public Version Status: New
• Public Device Record Key: aac382a9-35ff-4216-82da-7a2d51e42ff6

Device Description

PK OF 5

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: Yes
• Sterilization Methods: Sound Waves

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EJF	Bracket, Metal, Orthodontic	Dental	872.5410	1

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	06970469418606	GS1