Andorate®

GUDID 16970661241542

Smartdata Suzhou Co., Ltd.

Endoscopic biopsy valve, single-use

• Primary Device ID: 16970661241542
• NIH Device Record Key: 9f868b28-28d7-42f0-ac80-b966b7559679
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Andorate®
• Version Model Number: GAR028S
• Company DUNS: 529507479
• Company Name: Smartdata Suzhou Co., Ltd.
• 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	06970661241545 [Primary]
GS1	16970661241542 [Package]; Contains: 06970661241545; Package: Outer Box [100 Units]; In Commercial Distribution
GS1	26970661241549 [Package]; Package: Carton [10 Units]; In Commercial Distribution

FDA Product Code

• OCX: Endoscopic Irrigation/Suction System

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-10-02
• Device Publish Date: 2018-10-02

On-Brand Devices [Andorate®]

• 16970661241733: GAR014
• 16970661241542: GAR028S
• 16970661241498: GAR023
• 16970661241030: GAR004C
• 16970661240330: GAR004