andorate® Universal Endoscope Tip Guard

GUDID 14897106952899

GA Health Company Limited

Surgical instrument guard, single-use, sterile

• Primary Device ID: 14897106952899
• NIH Device Record Key: 21bf3cac-894a-42a5-842d-40172f73f5d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: andorate® Universal Endoscope Tip Guard
• Version Model Number: GAR107-S
• Company DUNS: 686908512
• Company Name: GA Health Company Limited
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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	04897106952892 [Primary]
GS1	14897106952899 [Package]; Contains: 04897106952892; Package: Box [50 Units]; In Commercial Distribution
GS1	24897106952896 [Package]; Package: Carton [4 Units]; In Commercial Distribution

FDA Product Code

• OCU: Endoscopic Storage Cover

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-07
• Device Publish Date: 2022-01-28

On-Brand Devices [andorate® Universal Endoscope Tip Guard]

• 14897106953544: GAR107
• 14897106952899: GAR107-S