Andorate

GUDID 06970934720074

GA Health Company Limited

Endoscopic bite block, basic, single-use

• Primary Device ID: 06970934720074
• NIH Device Record Key: 91de32c5-87e3-4b39-bfcf-2de11d87abef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Andorate
• Version Model Number: GAR044
• Company DUNS: 544333811
• Company Name: GA Health Company Limited
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970934720074 [Primary]
GS1	16970934720071 [Package]; Package: Outer box [100 Units]; In Commercial Distribution
GS1	26970934720078 [Package]; Contains: 16970934720071; Package: Outer case [4 Units]; In Commercial Distribution

FDA Product Code

• MNK: Endoscopic Bite Block

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-10-11
• Device Publish Date: 2018-09-10

Devices Manufactured by GA Health Company Limited

• 14897106955531 - andorate® Champion 3-piece valve kit: 2024-10-17
• 04897106953363 - andorate® 2-piece Valve Kit: 2024-10-14
• 14897106954626 - andorate® Suction Valve: 2024-10-14
• 14897106955166 - andorate® Biopsy Valve: 2024-10-14
• 14897106955562 - andorate® Champion 4-piece valve kit: 2024-10-14
• 14897106955579 - andorate® Champion 3-piece valve kit: 2024-10-14
• 14897106955616 - andorate® Champion 3-piece valve kit: 2024-10-14
• 14897106955647 - andorate® Champion 4-piece valve kit: 2024-10-14