Thoracoscope

GUDID 04059082003559

SOPRO-COMEG GmbH

Rigid optical thoracoscope

• Primary Device ID: 04059082003559
• NIH Device Record Key: 76732471-0e97-4542-9c91-d03a936bc33c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Thoracoscope
• Version Model Number: 162 101 702BC001
• Company DUNS: 507185952
• Company Name: SOPRO-COMEG GmbH
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04059082003559 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K945263

FDA Product Code

• GCJ: Laparoscope, general & plastic surgery

Sterilization

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

[04059082003559]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-08
• Device Publish Date: 2016-09-12

On-Brand Devices [Thoracoscope]

• 04059082032177: 162 101 702
• 04059082003559: 162 101 702BC001