IOLMaster 700

Primary DI
04049471092080
Brand
IOLMaster 700
Company
Carl Zeiss Meditec AG
Model
IOLMaster 700
Device description
The IOLMaster 700 is intended for biometric measurements and visualization of ocular structures. The measurements and visualization assist in the determination of the appropriate power and type of intraocular lens. The IOLMaster 700 measures:• Lens thickness• Corneal curvature and thickness• Axial length• Anterior chamber depth• Pupil diameter• White-to-white distance (WTW)For visualization, the IOLMaster 700 employs optical coherence tomography (OCT) to obtain two-dimensional images of ocular structures of the anterior and posterior segments of the eye.The Reference Image functionality is intended for use as a preoperative and postoperative image capture tool.
Published
2016-07-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HJOBiomicroscope, Slit-Lamp, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HJOBiomicroscope, Slit-Lamp, Ac-PoweredOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049471092080PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049471092080040494710920804049471092080

GMDN Terms#

Term, Definition table
TermDefinition
Optical low coherence reflectometry (OLCR) biometerA mains electricity (AC-powered) ophthalmic device (a biometer) designed to determine the axial dimensions and frontal section of the eye including other biometric parameters/evaluations such as keratometry, white-to-white distance, pupillometry and consequently corneal power based on optical low coherence reflectometry (OLCR), non contact, measurement methods using light markers and digital image processing. It is normally adjustable on a cross stage with an integral chin rest and used to obtain measurements directly from the eye for processing and display via software, e.g., in an attached computer. Patient intraocular lens (IOL) suitability may also be calculated using different formulae.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity30 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius35 Degrees Celsius
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
314594680
Device count
1
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

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