DEVICE: Clement Clarke Ophthalmic (05060179470146)

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Device Identifier (DI) Information

Clement Clarke Ophthalmic
6403001ULUS
6403001ULUS
HAAG-STREIT UK LIMITED
05060179470146
GS1
1
SYNOPTOPHORE MODEL 2003 (11)
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
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
Synoptophor, line-powered A mains electricity (AC-powered) ophthalmic device used for the evaluation and training of a patient's binocular function, i.e., the ability of the two eyes to focus on a single object. It is used for diagnosing strabismus (squinting), a deviation of the eye which the patient cannot overcome and present in variants such as stereoscopy (vision in depth), amblyopia otherwise known as lazy eye (dimness of vision without apparent disease of the eye), and diplopia [exotropia (outward eye deviation) or esotropia (one or both eyes turn inward)]. It typically consists of a base with twin vision tubes (adjustable in many axes) providing images and illumination.
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FDA Product Code

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Product Code Product Code Name
HJQ Stereoscope, Ac-Powered
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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 Status

In Commercial Distribution
July 22, 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
Yes
No CLOSE

Customer Contact

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+4401279414969
twhay@ccholdingsltd.com
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