16X KLO Metal Self-Ligating Narrow +5.0

GUDID 06970469418651

PK OF 5

Zhejiang Headway Medical Equipment Co., Ltd

Orthodontic bracket, metal

• Primary Device ID: 06970469418651
• NIH Device Record Key: b1f4619e-72f0-4e0c-b5d4-8a568d0a33e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 16X KLO Metal Self-Ligating Narrow +5.0
• Version Model Number: BR16X-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	06970469418651 [Primary]

FDA Product Code

• EJF: Bracket, Metal, Orthodontic

Sterilization

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

[06970469418651]

Sound Waves

[06970469418651]

Sound Waves

[06970469418651]

Sound Waves

[06970469418651]

Sound Waves

[06970469418651]

Sound Waves

[06970469418651]

Sound Waves

[06970469418651]

Sound Waves

[06970469418651]

Sound Waves

[06970469418651]

Sound Waves

[06970469418651]

Sound Waves

[06970469418651]

Sound Waves

[06970469418651]

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 [16X KLO Metal Self-Ligating Narrow +5.0 ]

• 06970469419030: PK OF 100
• 06970469418651: PK OF 5