DEVICE: TRICAM® (04048551064092)

Device Identifier (DI) Information

TRICAM®
20221139
In Commercial Distribution

Karl Storz GmbH & Co. KG
04048551064092
GS1

1
315731430 *Terms of Use
TRICAM-P PDD/AF Camera Head NTSC
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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
Endoscope video camera An electro-optical device (e.g., a CCD) designed to be attached, either directly or with an adaptor, to a flexible or rigid endoscope to allow real-time viewing of the internal anatomy during an endoscopic surgical procedure and to obtain moving-picture documentation of endoscopic findings and procedures. The device is designed for transducing visual images as a sequence of electronic data following a pre-established standard; the images are usually displayed sequentially on the screen of a monitor as a video image. The device may include audio recording capabilities.
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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 000
No CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Hydrogen Peroxide
High-level Disinfectant
Ethylene Oxide
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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

b6fac602-216f-4d35-8d7f-baddd3ef3ac1
July 06, 2018
3
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

[?]
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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