DEVICE: 3.6V STREAK RET & PROF OPHTH (05055272701686)
Device Identifier (DI) Information
3.6V STREAK RET & PROF OPHTH
1427-P-1059
In Commercial Distribution
KEELER LIMITED
1427-P-1059
In Commercial Distribution
KEELER LIMITED
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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46784 | Retinoscope, line-powered |
A mains electricity (AC-powered), hand-held, ophthalmic device that is used to measure the refractive errors of the eye through the projection of a beam of light into the eye, and the observation of the movement of the illuminated area on the retinal surface and of the refraction of the emergent rays. The current power is run through a transformer for reduction to low-voltage. Also known as a skiascope and the method as sciascopy.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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HKL | Retinoscope, Ac-Powered |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
9c3943fc-cd9c-4161-8fbb-f3dc0d51d117
March 29, 2018
2
August 26, 2016
March 29, 2018
2
August 26, 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 |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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
[?]
No Customer Contact currently defined