DEVICE: MINIATURE LIGHT SOURCE (04953170060601)

Device Identifier (DI) Information

MINIATURE LIGHT SOURCE
MAJ-524
In Commercial Distribution

OLYMPUS MEDICAL SYSTEMS CORP.
04953170060601
GS1

1
711789789 *Terms of Use
MAJ-524 MINATURE LIGHT SOURCE F/ LF-TP/D
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
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?
35906 Endoscopic light source unit, battery-powered
A battery-powered device designed to produce light of high intensity, often called cold light, for viewing surgical fields and body cavities when using rigid or flexible endoscopes (e.g., laparoscopes, gastroscopes). It is typically designed as a portable endoscope attachment whereby the bright light is channelled to the endoscope to illuminate the site of observation/intervention while minimizing tissue heating. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
EOB NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K013591 000
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Sterilization

No
Yes
Sterilization Method [?]
Ethylene Oxide
High-level Disinfectant
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Storage and Handling

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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

9aba5835-6610-4a40-a6c0-2c7d38d103aa
April 22, 2024
8
September 21, 2016
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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

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
+1(800)401-1086
xx@xx.xx
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