Thoracoscope

Basic Information

• Brand Name: Thoracoscope
• Primary DI: 04059082032177
• Version / Model: 162 101 702
• Company Name: SOPRO-COMEG GmbH
• Labeler DUNS: 507185952
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-03-20
• Public Version: 4
• Public Version Date: 2019-11-08
• Public Version Status: Update
• Public Device Record Key: ca4ed63d-d705-447c-b4b1-c4d173792b2b

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GCJ	Laparoscope, general & plastic surgery	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35398	Rigid optical thoracoscope	An endoscope with a rigid inserted portion intended for the visual examination and treatment of the thoracic cavity. It is inserted through an incision made in the chest into the intercostal cavity. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04059082032177	GS1

Premarket Submissions

Submission Number	Supplement Number
K945263	000