DEVICE: MediWorks (06945087517017)
Device Identifier (DI) Information
MediWorks
T170(R)
In Commercial Distribution
SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.
T170(R)
In Commercial Distribution
SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.
Tonometer is indicated for Intraocular Pressure (IOP) measurement .
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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32721 | Ophthalmic tonometer, manual |
An ophthalmic, manually-operated, measuring instrument designed for determining the intraocular pressure (IOP) by exerting an external force in direct contact with the eye which provides a reading of the resistance of the tunica of the eye to deformation (the extent of corneal indentation) which is expressed in millimetre(s) of mercury (mmHg). This device (known as a contact type, e.g., a Schioetz or Perkins tonometer) is used in the diagnosis of glaucoma and may be hand-held or used in conjunction with a slit lamp.
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FDA Product Code
[?]Product Code | Product Code Name |
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HKY | Tonometer, Manual |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K142263 | 000 |
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
1edb1394-8b18-479b-9547-6f052f913f90
January 18, 2021
5
August 01, 2016
January 18, 2021
5
August 01, 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
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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