DEVICE: ATMOS (04250365189797)
Device Identifier (DI) Information
ATMOS
LS 31 LED
In Commercial Distribution
ATMOS MedizinTechnik GmbH & Co. KG
LS 31 LED
In Commercial Distribution
ATMOS MedizinTechnik GmbH & Co. KG
The product is a cold light source for medical use. In combination with a light guide cable and an instrument connected to it, the light source enables the illumination of the viewing area for diagnostic purposes.
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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35158 | Endoscopic light source unit, line-powered |
A mains electricity (AC-powered) unit designed to produce light of high intensity, often called cold light, for viewing surgical fields and body cavities during endoscopy (e.g., used with an arthroscope, cystoscope, laparoscope, gastroscope); it may have additional non-endoscopic lighting applications. It is designed as a bench-top unit with controls and a source of bright light [e.g., using a xenon (Xe) light bulb] that is channelled to the endoscope via a light cable to illuminate the site of observation/intervention while minimizing tissue heating.
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FDA Product Code
[?]Product Code | Product Code Name |
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KZF | Device, Medical Examination, Ac Powered |
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
9fd93ca6-4dc2-4a87-bc89-2fd0e70151fb
December 05, 2024
1
November 27, 2024
December 05, 2024
1
November 27, 2024
Alternative and Additional Identifiers Additional Identifiers
Package DI
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Secondary DI
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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
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Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined