DEVICE: C-Camsource® (04250337106166)

Device Identifier (DI) Information

C-Camsource®
CSDHD8000P
In Commercial Distribution
CSDHD8000P
Joimax GmbH
04250337106166
GS1

1
344267187 *Terms of Use
D-Camsource® HD LED
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
Yes
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?
34540 Endoscopic video image processing/light source system
A mains electricity (AC-powered) unit/assembly that, when used with an appropriate endoscope (not included), is designed to both: 1) produce a source of cold light for endoscopic imaging; and 2) receive and process electronic video image signals sent from the endoscope/endoscopic video camera. It may additionally include image recording features and an image display monitor, however it does not include features to steer, propel or otherwise control the movement of the endoscope.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FWF CAMERA, TELEVISION, ENDOSCOPIC, WITHOUT AUDIO
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

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

[?]
Storage and Handling
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -25 and 70 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: camera and lightsource system with dual cable
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Device Record Status

c9241d25-18f9-43ba-9f52-6a438acdfdbc
January 09, 2023
1
December 30, 2022
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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
Yes
No CLOSE

Customer Contact

[?]
+497212551407010
info@joimax.com
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