DEVICE: Digital Refractor (06971922130073)
Device Identifier (DI) Information
Digital Refractor
YPA-2100
Not in Commercial Distribution
Chongqing Yeasn Science & Technology Co.,Ltd.
YPA-2100
Not in Commercial Distribution
Chongqing Yeasn Science & Technology Co.,Ltd.
To check the refractive state of human eye.
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? |
|---|---|---|---|---|
| 66911 | Phoropter, manual |
A manually-operated ophthalmic device intended to be placed in front of a patient's eyes to assist with measuring the refractive error of the eye (the inaccuracies of focusing light upon the retina) during an examination, typically to determine a patient's prescription for glasses. Also known as a manual refractor, it typically consists of two mounted disk-like housings (head) which contain lenses of different characteristics. The optometrist manually changes the lenses and other settings while asking the patient to read an eye chart and provide subjective feedback on which settings give best vision.
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Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| HKN | Refractor, Manual, Non-Powered, Including Phoropter |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| 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
2996a9b9-7a11-4f4a-940a-c52b946193cb
August 22, 2024
3
October 22, 2020
August 22, 2024
3
October 22, 2020
Alternative and Additional Identifiers Additional Identifiers
Package DI
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Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
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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