DEVICE: TRICAM® (04048551064160)

Device Identifier (DI) Information

TRICAM®
20223011U1
In Commercial Distribution

Karl Storz GmbH & Co. KG
04048551064160
GS1

1
315731430 *Terms of Use
CCU, TRICAM®, SL II, SCB
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Device Characteristics

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

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Endoscopic video image processing unit A mains electricity (AC-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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FDA Product Code

[?]
Product Code Product Code Name
OAY Light Source System, Diagnostic Endoscopic
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P050027 001
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

df313793-5107-4da4-997f-4940d88d6db1
February 21, 2019
4
September 24, 2014
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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
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
424-218-8201
su.chen@karlstorz.com
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