DEVICE: MediWorks (06945087536018)

Device Identifier (DI) Information

MediWorks
S360
In Commercial Distribution

SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.
06945087536018
GS1

1
527884077 *Terms of Use
Slit Lamp Microscopes are used to observe the disease of the anterior structures and tissue damage of eyes.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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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?
35148 Ophthalmic examination slit lamp
An electrically-powered, ophthalmic, binocular microscope designed to examine the interior anatomy of the eye by viewing through the pupil; it is not dedicated to surgical procedures. It projects a narrow slit of light into the eye and resulting light reflections are detected obliquely with a travelling microscope to enable observation of the internal ocular structures. It is used to perform a variety of measurements [e.g., intraocular pressure (IOP) or tonometry, corneal thickness, anterior chamber depth] and to evaluate symptoms (e.g., eye itchiness, grittiness, pain, dry eyes, photophobia, and reduced visual acuity).
Active false
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FDA Product Code

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Product Code Product Code Name
HJO Biomicroscope, Slit-Lamp, Ac-Powered
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K152429 000
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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

74cd1a16-f079-4bf4-8311-aace72540bf4
December 20, 2022
8
August 01, 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
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Customer Contact

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No Customer Contact currently defined
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