DEVICE: schiötz A tonometer, straight scale, silver (04045396007086)
Device Identifier (DI) Information
schiötz A tonometer, straight scale, silver
5110
In Commercial Distribution
5110
Rudolf Riester GmbH
5110
In Commercial Distribution
5110
Rudolf Riester GmbH
The eye tonometer used to measuring the intra-ocular pressure.
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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16809 | Ophthalmic tonometer, battery-operated |
An ophthalmic, battery-powered, measuring instrument designed for determining the intraocular pressure (IOP) by exerting an external force against 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 hand-held device (known as a contact type, e.g., a Perkins tonometer) is often used for, e.g., the examination of postoperative, bedridden and paediatric patients.
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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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K945541 | 000 |
Sterilization
Storage and Handling
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No storage/handling found |
Clinically Relevant Size
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No Device Sizes |
Device Record Status
68d8aa88-ca38-4a8b-9d5d-50a424b581bd
July 06, 2018
3
September 20, 2016
July 06, 2018
3
September 20, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
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Secondary DI
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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)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined