Ovitz Aberrometer

GUDID 08908007754082

OVITZ P10 is an ophthalmic aberrometer. It uses Wavefront Sensing technology for accurate and reliable refractive measurements in human eyes. It is compact and completely portable, with a light weight body and long-lasting battery. It has a high resolution, touchscreen color display. An ergonomic handle gives the user a comfortable control in handling of the device.

FORUS HEALTH PRIVATE LIMITED

Ophthalmic refractometer, automated

• Primary Device ID: 08908007754082
• NIH Device Record Key: fd9566d5-2550-45f9-9df8-5114e5d7ae04
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ovitz Aberrometer
• Version Model Number: P10
• Company DUNS: 864213893
• Company Name: FORUS HEALTH PRIVATE LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08908007754082 [Primary]

FDA Product Code

• HKO: Refractometer, Ophthalmic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-03-05
• Device Publish Date: 2019-08-22

Devices Manufactured by FORUS HEALTH PRIVATE LIMITED

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• 08908007754112 - 3nethra: 2020-10-19 3nethra classic is a compact, portable and easy-to-use ophthalmic camera that supports non-mydriatic imaging mode. It is design
• 08908007754129 - 3nethra: 2020-10-19 3nethra classic is a compact, portable and easy-to-use ophthalmic camera that supports non-mydriatic imaging mode. It is design
• 08908007754099 - 3nethra: 2020-07-13 3nethra classic HD is an ophthalmic camera intended to capture and document digital images of the human eye.
• 08908007754105 - 3nethra: 2020-07-13 3nethra classic HD is an ophthalmic camera intended to capture and document digital images of the human eye.
• 08908007754082 - Ovitz Aberrometer: 2020-03-05OVITZ P10 is an ophthalmic aberrometer. It uses Wavefront Sensing technology for accurate and reliable refractive measurements in human eyes. It is compact and completely portable, with a light weight body and long-lasting battery. It has a high resolution, touchscreen color display. An ergonomic handle gives the user a comfortable control in handling of the device.
• 08908007754082 - Ovitz Aberrometer: 2020-03-05 OVITZ P10 is an ophthalmic aberrometer. It uses Wavefront Sensing technology for accurate and reliable refractive measurements