FDA.report

NON CONTACT TONOMETER

Primary DI
04987669100431
Brand
NON CONTACT TONOMETER
Company
NIDEK CO.,LTD.
Model
NT-530
Device description
The NON CONTACT TONOMETER Model NT-530 is designed for non-contact tonometry measurement. The non-contact tonometry function measures the intraocular
Published
2016-06-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HKXTonometer, Ac-Powered

Product Code Classifications

CodeDeviceSpecialtyClass
HKXTonometer, Ac-PoweredOphthalmic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04987669100431PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04987669100431049876691004314987669100431

GMDN Terms

TermDefinition
Ophthalmic tonometer, line-poweredAn ophthalmic, line-powered, measuring instrument used 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). It typically has no contact with the eye and can use various techniques, e.g., the air-puff tonometer records deflections of the cornea from a puff of pressurized air; the applanation tonometer records the indentation pressure in thousands of a second. It is used for the diagnosis of glaucoma, designed for table top use and may provide the data on a screen and/or a print-out.

Sterilization Methods

Method

Contacts

PhoneEmail
1-800-223-9044info@nidek.com

Regulatory Flags

DUNS number
690635461
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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