DEVICE: Icare tonometer probes (06430033850565)
Device Identifier (DI) Information
Device Characteristics
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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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62405 | Ophthalmic tonometer probe |
A device intended to be attached to an ophthalmic tonometer and to make brief and gentle contact with the eye surface for the measurement of intraocular pressure (IOP). It may be in the form of a prism with a dedicated mount (mount may be included with the device) or a thin metal or plastic rod with a plastic distal tip designed to be moved towards the eye by the tonometer (e.g., via magnetization), which uses probe deceleration and rebound time measurements to calculate IOP. This is a single-use device.
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FDA Product Code
[?]Product Code | Product Code Name |
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HKX | Tonometer, Ac-Powered |
HKY | Tonometer, Manual |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K063873 | 000 |
K153694 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
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No Device Sizes |
Device Record Status
abcb24ee-8c10-42b8-893e-17f38d8df3b9
February 20, 2023
4
December 01, 2016
February 20, 2023
4
December 01, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
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No Package DIs found |
Secondary DI
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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
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No Customer Contact currently defined