DEVICE: HALOGEN LAMP (04953170063350)
Device Identifier (DI) Information
HALOGEN LAMP
MAJ-525
In Commercial Distribution
GJ2031
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-525
In Commercial Distribution
GJ2031
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-525 HALOGEN LAMP SET F/THE LF-TP/DP
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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EOB | Nasopharyngoscope (Flexible Or Rigid) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K013591 | 000 |
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
d3d1bab8-c793-443a-8263-ecc393a375e7
April 22, 2024
8
September 21, 2016
April 22, 2024
8
September 21, 2016
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
84953170063356
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)401-1086
xx@xx.xx
xx@xx.xx