Quest Laparoscope ART-LAP-0006

GUDID 08719324487016

Quest Projects B.V.

Rigid optical laparoscope

• Primary Device ID: 08719324487016
• NIH Device Record Key: 3f30ae2d-4a68-419a-b3da-ee1859fb1b37
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Quest Laparoscope
• Version Model Number: ART-LAP-0006
• Catalog Number: ART-LAP-0006
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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	08719324487016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K945266

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

Sterilization

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

[08719324487016]

Moist Heat or Steam Sterilization

[08719324487016]

Moist Heat or Steam Sterilization

[08719324487016]

Moist Heat or Steam Sterilization

[08719324487016]

Moist Heat or Steam Sterilization

[08719324487016]

Moist Heat or Steam Sterilization

[08719324487016]

Moist Heat or Steam Sterilization

[08719324487016]

Moist Heat or Steam Sterilization

[08719324487016]

Moist Heat or Steam Sterilization

[08719324487016]

Moist Heat or Steam Sterilization

[08719324487016]

Moist Heat or Steam Sterilization

[08719324487016]

Moist Heat or Steam Sterilization

[08719324487016]

Moist Heat or Steam Sterilization

[08719324487016]

Moist Heat or Steam Sterilization

[08719324487016]

Moist Heat or Steam Sterilization

[08719324487016]

Moist Heat or Steam Sterilization

[08719324487016]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-11-23
• Device Publish Date: 2016-09-14

On-Brand Devices [Quest Laparoscope]

• 08719324487023: ART-LAP-0007
• 08719324487016: ART-LAP-0006