3D Laparoscope

GUDID 06973031299344

Guangdong Optomedic Technologies, Inc.

Rigid optical laparoscope

• Primary Device ID: 06973031299344
• NIH Device Record Key: c48b3564-7ec5-471a-bc6a-da4cfbe919ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3D Laparoscope
• Version Model Number: 21033SA
• 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	06973031299344 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241530

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

Sterilization

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

[06973031299344]

Moist Heat or Steam Sterilization

[06973031299344]

Moist Heat or Steam Sterilization

[06973031299344]

Moist Heat or Steam Sterilization

[06973031299344]

Moist Heat or Steam Sterilization

[06973031299344]

Moist Heat or Steam Sterilization

[06973031299344]

Moist Heat or Steam Sterilization

[06973031299344]

Moist Heat or Steam Sterilization

[06973031299344]

Moist Heat or Steam Sterilization

[06973031299344]

Moist Heat or Steam Sterilization

[06973031299344]

Moist Heat or Steam Sterilization

[06973031299344]

Moist Heat or Steam Sterilization

[06973031299344]

Moist Heat or Steam Sterilization

[06973031299344]

Moist Heat or Steam Sterilization

[06973031299344]

Moist Heat or Steam Sterilization

[06973031299344]

Moist Heat or Steam Sterilization

[06973031299344]

Moist Heat or Steam Sterilization

[06973031299344]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-23
• Device Publish Date: 2024-08-15

On-Brand Devices [3D Laparoscope]

• 06973031299344: 21033SA
• 06973031299337: 21033SC