07X KLO Metal Self-Ligating -5.0

GUDID 06970469418569

PK OF 5

Zhejiang Headway Medical Equipment Co., Ltd

Orthodontic bracket, metal

• Primary Device ID: 06970469418569
• NIH Device Record Key: e358da0b-8de9-4a12-8e66-7b404cc72f03
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 07X KLO Metal Self-Ligating -5.0
• Version Model Number: BR07X-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	06970469418569 [Primary]

FDA Product Code

• EJF: Bracket, Metal, Orthodontic

Sterilization

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

[06970469418569]

Sound Waves

[06970469418569]

Sound Waves

[06970469418569]

Sound Waves

[06970469418569]

Sound Waves

[06970469418569]

Sound Waves

[06970469418569]

Sound Waves

[06970469418569]

Sound Waves

[06970469418569]

Sound Waves

[06970469418569]

Sound Waves

[06970469418569]

Sound Waves

[06970469418569]

Sound Waves

[06970469418569]

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

Devices Manufactured by Zhejiang Headway Medical Equipment Co., Ltd

• 06970469418514 - 02X KLO Metal Self-Ligating +5.2: 2025-12-04 PK OF 5
• 06970469418521 - 03X KLO Metal Self-Ligating +5.4: 2025-12-04 PK OF 5
• 06970469418538 - 04X KLO Metal Self-Ligating +15.0: 2025-12-04 PK OF 5
• 06970469418545 - 05X KLO Metal Self-Ligating +15.2: 2025-12-04 PK OF 5
• 06970469418552 - 06X KLO Metal Self-Ligating +15.4: 2025-12-04 PK OF 5
• 06970469418569 - 07X KLO Metal Self-Ligating -5.0: 2025-12-04PK OF 5
• 06970469418569 - 07X KLO Metal Self-Ligating -5.0: 2025-12-04 PK OF 5
• 06970469418576 - 08X KLO Metal Self-Ligating -5.2: 2025-12-04 PK OF 5
• 06970469418583 - 09X KLO Metal Self-Ligating -5.4: 2025-12-04 PK OF 5