DEVICE: SPECULAR MICROSCOPE SP-1P (04562123288315)

Device Identifier (DI) Information

SPECULAR MICROSCOPE SP-1P
SP-1P
In Commercial Distribution

TOPCON CORPORATION
04562123288315
GS1

1
690542881 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
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No
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Yes
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Microscope still camera An electro-optical device designed to generate an enlarged photograph of a microscope field and its contents. This device is designed to utilize the lens system of the microscope in order to magnify the field. It may be attached to laboratory and/or surgical microscopes to document laboratory examinations and surgical procedures, respectively. Included are digital and photographic film cameras.
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FDA Product Code

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Product Code Product Code Name
NQE Microscope, specular
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FDA Premarket Submission

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

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Sterilization Method [?]
No Sterilization Methods Found
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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

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Size Type Text
No Device Sizes
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Device Record Status

1919c487-ec5d-481c-8f09-de28a4f38252
March 29, 2018
2
September 19, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
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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)

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No
None
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Production Identifier(s) in UDI

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Customer Contact

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No Customer Contact currently defined
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