Quest Spectrum Kit for open surgery

GUDID 08719324487030

kit for open surgery: 1x indocyanine Green for injection, USP 25mg vial 1x sterile water for injection, USP 10ml vial 1x1 piece drape art-drp-0-004

Quest Projects B.V.

Surgical microscope fluorescent angiography system

• Primary Device ID: 08719324487030
• NIH Device Record Key: 4f81fe34-4e75-44b5-ab22-e91de2f4b33c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Quest Spectrum Kit for open surgery
• Version Model Number: ART-ICG-0001
• Company DUNS: 386614502
• Company Name: Quest Projects B.V.
• 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: true
• 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	08719324487030 [Primary]

FDA Product Code

• OWN: Confocal Optical Imaging

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: 2020-03-12
• Device Publish Date: 2020-03-04

Devices Manufactured by Quest Projects B.V.

• 08719324487016 - Quest Laparoscope: 2021-11-23
• 08719324487023 - Quest Laparoscope: 2021-11-23
• 08719324487030 - Quest Spectrum Kit for open surgery: 2020-03-12kit for open surgery: 1x indocyanine Green for injection, USP 25mg vial 1x sterile water for injection, USP 10ml vial 1x1 piece drape art-drp-0-004
• 08719324487030 - Quest Spectrum Kit for open surgery: 2020-03-12 kit for open surgery: 1x indocyanine Green for injection, USP 25mg vial 1x sterile water for in