DEVICE: Clement Clarke Ophthalmic (05060179470313)

Device Identifier (DI) Information

Clement Clarke Ophthalmic
5606013 US
In Commercial Distribution
5606013 US
HAAG-STREIT UK LIMITED
05060179470313
GS1

1
296887714 *Terms of Use
BA904 SLIT LAMP SET C (05)
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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
Ophthalmic slit lamp, examination A mains electricity (AC-powered), ophthalmic, binocular microscope designed to examine the interior anatomy of the eye (anterior and posterior surfaces) by viewing through the iris. It produces a narrow slit of powerful light which is projected into the eye, and resulting light reflections are detected obliquely with a travelling microscope to enable observation of the internal ocular surfaces. 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).
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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 [?]
K953965 000
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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 Record Status

49f129b0-0af3-4592-9388-4db37bed0b86
July 06, 2018
3
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)

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

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Yes
Yes
No
Yes
No CLOSE

Customer Contact

[?]
+4401279414969
twhay@ccholdingsltd.com
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