DEVICE: IMAGE1 CONNECT (04048551356586)
Device Identifier (DI) Information
IMAGE1 CONNECT
TC200US
In Commercial Distribution
Karl Storz GmbH & Co. KG
TC200US
In Commercial Distribution
Karl Storz GmbH & Co. KG
CCU,MODULAR,IMAGE 1 CONNECT,US
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
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Endoscopic video image processor | A mains electricity (AC-powered) device designed to receive the electronic signals sent from a video endoscope or endoscopic video camera for the purpose of processing them. It may have additional features which compensate for/enhance the colour and light qualities provided. The picture images are sent to and shown on a visual display unit (VDU), typically to assist the endoscope operator with an ongoing intervention and often to allow the patient visualization of the process, and also the images can be recorded on a video recorder or stored on computerized media. Hard copy pictures can also be produced through the use of other devices. |
FDA Product Code
[?]Product Code | Product Code Name |
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FET | Endoscopic video imaging system/component, gastroenterology-urology |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
d9dcd7e2-a2d9-4aa0-8485-463f99327003
March 29, 2018
2
September 23, 2016
March 29, 2018
2
September 23, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined