28X KLO Metal Self-Ligating -5.0 K1 (LEFT HOOK)

GUDID 06970469418774

PK OF 5

Zhejiang Headway Medical Equipment Co., Ltd

Orthodontic bracket, metal

• Primary Device ID: 06970469418774
• NIH Device Record Key: 8804e305-816f-4901-b073-2df0d7b9d4c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 28X KLO Metal Self-Ligating -5.0 K1 (LEFT HOOK)
• Version Model Number: BR28X-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	06970469418774 [Primary]

FDA Product Code

• EJF: Bracket, Metal, Orthodontic

Sterilization

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

[06970469418774]

Sound Waves

[06970469418774]

Sound Waves

[06970469418774]

Sound Waves

[06970469418774]

Sound Waves

[06970469418774]

Sound Waves

[06970469418774]

Sound Waves

[06970469418774]

Sound Waves

[06970469418774]

Sound Waves

[06970469418774]

Sound Waves

[06970469418774]

Sound Waves

[06970469418774]

Sound Waves

[06970469418774]

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 [28X KLO Metal Self-Ligating -5.0 K1 (LEFT HOOK)]

• 06970469419153: PK OF 100
• 06970469418774: PK OF 5