DEVICE: Clement Clarke Ophthalmic (05060179470030)
Device Identifier (DI) Information
Clement Clarke Ophthalmic
6402001ULUS
In Commercial Distribution
6402001ULUS
HAAG-STREIT UK LIMITED
6402001ULUS
In Commercial Distribution
6402001ULUS
HAAG-STREIT UK LIMITED
SYNOPTOPHORE MODEL 2002 (11)
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 |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HJQ | Stereoscope, Ac-Powered |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
d45469fc-f4df-44a3-8688-6e11405f1c1a
November 09, 2023
4
July 22, 2016
November 09, 2023
4
July 22, 2016
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+4401279414969
twhay@ccholdingsltd.com
twhay@ccholdingsltd.com