andorate® Bite Block 55.5Fr with Strap

GUDID 14897106953582

GA Health Company Limited

Endoscopic bite block, basic, single-use

• Primary Device ID: 14897106953582
• NIH Device Record Key: 690889b2-ac28-4d37-b990-0233bc19098e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: andorate® Bite Block 55.5Fr with Strap
• Version Model Number: SDPC0209A
• Company DUNS: 686908512
• 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: false
• Expiration Date: true
• 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	04897106953585 [Primary]
GS1	14897106953582 [Package]; Contains: 04897106953585; Package: Box [100 Units]; In Commercial Distribution
GS1	24897106953589 [Package]; Package: Carton [3 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: 2022-03-03
• Device Publish Date: 2022-02-23

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