21X KLO Metal Self-Ligating Narrow +15.4

GUDID 06970469418705

PK OF 5

Zhejiang Headway Medical Equipment Co., Ltd

Orthodontic bracket, metal

• Primary Device ID: 06970469418705
• NIH Device Record Key: c4080fd0-1d92-45ef-9127-37dd2135f4d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 21X KLO Metal Self-Ligating Narrow +15.4
• Version Model Number: BR21X-V
• Company DUNS: 412892520
• Company Name: Zhejiang Headway Medical Equipment Co., Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970469418705 [Primary]

FDA Product Code

• EJF: Bracket, Metal, Orthodontic

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[06970469418705]

Sound Waves

[06970469418705]

Sound Waves

[06970469418705]

Sound Waves

[06970469418705]

Sound Waves

[06970469418705]

Sound Waves

[06970469418705]

Sound Waves

[06970469418705]

Sound Waves

[06970469418705]

Sound Waves

[06970469418705]

Sound Waves

[06970469418705]

Sound Waves

[06970469418705]

Sound Waves

[06970469418705]

Sound Waves

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-04
• Device Publish Date: 2025-11-26

On-Brand Devices [21X KLO Metal Self-Ligating Narrow +15.4]

• 06970469419085: PK OF 100
• 06970469418705: PK OF 5