DEVICE: VIDEO PROCESSOR (04961333232611)
Device Identifier (DI) Information
VIDEO PROCESSOR
EPK-P
In Commercial Distribution
PENTAX OF AMERICA, INC.
EPK-P
In Commercial Distribution
PENTAX OF AMERICA, INC.
VIDEO PROCESSOR (REFURBISHED)
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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18034 | Endoscopic video image processing unit |
An electrically-powered device designed to receive and process the electronic signals sent from a video endoscope or endoscopic video camera; it does not include the endoscope nor light source and is not designed to control the endoscope. It may have additional features which compensate for/enhance the colour and light qualities provided. The resulting 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; the images can be recorded on a video recorder or stored on computerized media.
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Active | false |
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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K934918 | 000 |
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
37cf1ab2-fa34-47ef-9da3-c56c8efd6c70
October 30, 2023
5
April 06, 2017
October 30, 2023
5
April 06, 2017
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
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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