DEVICE: IOLMaster 700 (04049471092080)

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Device Identifier (DI) Information

IOLMaster 700
IOLMaster 700

Carl Zeiss Meditec AG
04049471092080
GS1
1
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
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Yes
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Optical low coherence reflectometry (OLCR) biometer A 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.
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FDA Product Code

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Product Code Product Code Name
HJO Biomicroscope, Slit-Lamp, Ac-Powered
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Sterilization

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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -10 and 55 Degrees Celsius
Handling Environment Humidity: between 30 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between 10 and 35 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Device Size Text, specify: Weight: approx. 27 kg
Device Size Text, specify: Height (measuring head): max. 563 mm
Device Size Text, specify: Dimensions (footprint): 439 mm x 389 mm
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Device Status

In Commercial Distribution
July 10, 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
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None
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Production Identifier(s) in UDI

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Customer Contact

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No Customer Contact currently defined
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