DEVICE: JEDMED (M6337101960)
Device Identifier (DI) Information
JEDMED
71-0196
In Commercial Distribution
71-0196
JEDMED INSTRUMENT COMPANY
71-0196
In Commercial Distribution
71-0196
JEDMED INSTRUMENT COMPANY
SLM 1 BASE PLATE & MAST W/FF
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
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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? |
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12538 | ENT surgical microscope |
A light (optical) magnification instrument designed to magnify minute structures (e.g., nerves, vessels) in the performance of ear, nose, and/or throat (ENT) surgery requiring high magnification and adjustable focusing. It typically consists of a stereo microscope (standard or modified) and a mobile floor stand or wall or ceiling mount. It is usually held by an adjustable arm attached to the support mechanism and equipped with motorized focusing, adjustable magnification systems (manual, zoom, or both), backup lamps, and inclined tubes. Dual- or multiple-observation capability and the optical integration of still, motion picture, and TV cameras are common features.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EPT | Microscope, Surgical |
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
d25b78cf-9c4d-41d4-9011-e8b9cd7d74f4
February 14, 2023
1
February 06, 2023
February 14, 2023
1
February 06, 2023
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined