DEVICE: NA (04582275250374)

Device Identifier (DI) Information

NA
NSPC
In Commercial Distribution

KONAN MEDICAL, INC.
04582275250374
GS1

1
690768619 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
No
No
No

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
Anterior eye segment analysis system analyser A mains electricity (AC-powered) ophthalmic instrument used to measure and evaluate various properties of the anterior eye segment (i.e., cornea, iris, pupil, anterior chamber and lens). It is typically used for corneal topography, pachymetry, pupillometry and three-dimensional (3-D) analysis of the anterior eye segment using, e.g., revolving dual-channel Scheimpflug photography (viewing of the anterior segment in a sagittal plane) and Placido imaging (involves a disk with concentric white and black rings). It is typically computerized and provides output to a system computer, or external computer, with installed dedicated application software.
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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 [?]
K062763 000
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Sterilization

No
No
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

44ba38ef-71eb-46c8-b66f-d2e145aaf190
July 06, 2018
3
September 23, 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
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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
Yes
No
No
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Customer Contact

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No Customer Contact currently defined
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