DEVICE: KOWA Applanation Tonometer HA-2 (04987646803799)

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Device Record History
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Device Identifier (DI) Information
KOWA Applanation Tonometer HA-2
ATO-6K
In Commercial Distribution

KOWA COMPANY,LTD.
04987646803799
GS1

1
692281073 *Terms of Use
For the measurement of intraocular pressure in the diagnosis of glaucoma.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
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Yes
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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?
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.
Obsolete false
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FDA Product Code

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Product Code Product Code Name
HKY Tonometer, Manual
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K960924 000
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Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between -15 and 60 Degrees Celsius
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
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Clinically Relevant Size

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Size Type Text
Weight: 240 Gram
Length: 290 Millimeter
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Device Record Status
746f17df-6224-41e0-afdf-1c8367fb320e
July 06, 2018
3
September 16, 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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No
Yes
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No
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Customer Contact

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No Customer Contact currently defined
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