DEVICE: Thoracoscope (04059082003559)

Device Identifier (DI) Information

Thoracoscope
162 101 702BC001
In Commercial Distribution

SOPRO-COMEG GmbH
04059082003559
GS1

1
507185952 *Terms of Use
No description.
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
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.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
GCJ Laparoscope, general & plastic surgery
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K945263 000
No CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

76732471-0e97-4542-9c91-d03a936bc33c
November 08, 2019
5
September 12, 2016
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE