DEVICE: Icare tonometer probes (06430033850565)

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Device Identifier (DI) Information

Icare tonometer probes
TP01s

ICARE FINLAND OY
06430033850565
GS1
1
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
Yes
No
Yes
Yes
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 tonometer probe, sterile A sterile 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 is 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 as single-use device.
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FDA Product Code

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Product Code Product Code Name
HKX Tonometer, Ac-Powered
HKY Tonometer, Manual
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Sterilization

Yes
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 Status

Not in Commercial Distribution
December 01, 2016
December 01, 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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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