ATOZ Expander Kit

GUDID 08800197900341

The ATOZ Expander Kit is a procedure kit used for orthodontic treatment and consists of an expander, screws, drivers, wires, and accessories. ATOZ Expander:MKE-08-F*1ea ATOZ Key: MK Key-L*1ea, MK Key-S*1ea ATOZ Mini-Screw: MKS-1611*8ea ATOZ Screwdriver MKD-S *1ea, MKD-L*1ea ATOZ Tooth connecting arms: MK Wire arm-1240*4ea

MK Meditech Inc.

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• Primary Device ID: 08800197900341
• NIH Device Record Key: b5cd9ca0-ba2e-4d6c-9641-0bbb2c4e1e96
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ATOZ Expander Kit
• Version Model Number: ATOZ Expander Kit
• Company DUNS: 695009476
• Company Name: MK Meditech Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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	08800197900341 [Primary]

FDA Product Code

• DYJ: Retainer, Screw Expansion, Orthodontic

Sterilization

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

[08800197900341]

Moist Heat or Steam Sterilization

[08800197900341]

Moist Heat or Steam Sterilization

[08800197900341]

Moist Heat or Steam Sterilization

[08800197900341]

Moist Heat or Steam Sterilization

[08800197900341]

Moist Heat or Steam Sterilization

[08800197900341]

Moist Heat or Steam Sterilization

[08800197900341]

Moist Heat or Steam Sterilization

[08800197900341]

Moist Heat or Steam Sterilization

[08800197900341]

Moist Heat or Steam Sterilization

[08800197900341]

Moist Heat or Steam Sterilization

[08800197900341]

Moist Heat or Steam Sterilization

[08800197900341]

Moist Heat or Steam Sterilization

[08800197900341]

Moist Heat or Steam Sterilization

[08800197900341]

Moist Heat or Steam Sterilization

[08800197900341]

Moist Heat or Steam Sterilization

[08800197900341]

Moist Heat or Steam Sterilization

[08800197900341]

Moist Heat or Steam Sterilization

[08800197900341]

Moist Heat or Steam Sterilization

[08800197900341]

Moist Heat or Steam Sterilization

[08800197900341]

Moist Heat or Steam Sterilization

[08800197900341]

Moist Heat or Steam Sterilization

[08800197900341]

Moist Heat or Steam Sterilization

[08800197900341]

Moist Heat or Steam Sterilization

[08800197900341]

Moist Heat or Steam Sterilization

[08800197900341]

Moist Heat or Steam Sterilization

[08800197900341]

Moist Heat or Steam Sterilization

[08800197900341]

Moist Heat or Steam Sterilization

[08800197900341]

Moist Heat or Steam Sterilization

[08800197900341]

Moist Heat or Steam Sterilization

[08800197900341]

Moist Heat or Steam Sterilization

[08800197900341]

Moist Heat or Steam Sterilization

[08800197900341]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-23
• Device Publish Date: 2023-10-13

On-Brand Devices [ATOZ Expander Kit]

• 08800197900075: ATOZ Expander Kit *10SET
• 08800197900068: The ATOZ Expander Kit is a procedure kit used for orthodontic treatment and consists of an expan
• 08800197900341: The ATOZ Expander Kit is a procedure kit used for orthodontic treatment and consists of an expan