Laparoscope

GUDID 06973031299665

Guangdong Optomedic Technologies, Inc.

Rigid optical laparoscope

• Primary Device ID: 06973031299665
• NIH Device Record Key: 154056d3-cb33-4bb8-922f-fff4c7bec663
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Laparoscope
• Version Model Number: 21033WC
• Company DUNS: 544527790
• Company Name: Guangdong Optomedic Technologies, Inc.
• 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: true
• 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	06973031299665 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231003

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

Sterilization

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

[06973031299665]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[06973031299665]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[06973031299665]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[06973031299665]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[06973031299665]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[06973031299665]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[06973031299665]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[06973031299665]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[06973031299665]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[06973031299665]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[06973031299665]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[06973031299665]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[06973031299665]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[06973031299665]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-03
• Device Publish Date: 2024-03-26

On-Brand Devices [Laparoscope]

• 06973031299665: 21033WC
• 06973031299658: 21033FA
• 06973031299641: 21033FC
• 06973031299634: 21033WA
• 06973031299627: 20533WA
• 06973031299610: 20533WC
• 06973031299603: 20533FA
• 06973031299597: 20533FC