DEVICE: Clement Clarke Ophthalmic (05060179470375)

Device Identifier (DI) Information

Clement Clarke Ophthalmic
7006001
In Commercial Distribution
7006001
HAAG-STREIT UK LIMITED
05060179470375
GS1

1
296887714 *Terms of Use
RAF BINOCULAR GAUGE
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Device Characteristics

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

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Binocular vision test unit An ophthalmic device for binocular vision testing. The patient views a four-dot light combination (1 white, 1 red and 2 green) through coloured glasses and informs the examining doctor when the combination perceived changes. This visual impression provides the information whereby a diagnosis of unconscious suppression of one eye can be determined.
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FDA Product Code

[?]
Product Code Product Code Name
HLE Ruler, Nearpoint (Punctometer)
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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

aa02e6ee-27f9-4c80-8ef9-bf0c288b00c6
March 29, 2018
2
August 05, 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
No
No
Yes
No CLOSE

Customer Contact

[?]
+4401279414969
twhay@ccholdingsltd.com
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