DEVICE: Clement Clarke Ophthalmic (05060179470030)

Device Identifier (DI) Information

Clement Clarke Ophthalmic
6402001ULUS
In Commercial Distribution
6402001ULUS
HAAG-STREIT UK LIMITED
05060179470030
GS1

1
504108242 *Terms of Use
SYNOPTOPHORE MODEL 2002 (11)
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Device Characteristics

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

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
36058 Synoptophore
An electrically-powered ophthalmic device intended to 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 (squint), 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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
HJQ Stereoscope, Ac-Powered
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FDA Premarket Submission

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

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

d45469fc-f4df-44a3-8688-6e11405f1c1a
November 09, 2023
4
July 22, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
Yes
No
Yes
No CLOSE

Customer Contact

[?]
+4401279414969
twhay@ccholdingsltd.com
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