Implantable Miniature Telescope (IMT™ by Dr. Isaac Lipshitz) PR00018-00

GUDID M687PR00018000

VISIONCARE OPHTHALMIC TECHNOLOGIES LTD.

Intraocular telescope Intraocular telescope Intraocular telescope Intraocular telescope Intraocular telescope Intraocular telescope Intraocular telescope Intraocular telescope Intraocular telescope Intraocular telescope Intraocular telescope Intraocular telescope

• Primary Device ID: M687PR00018000
• NIH Device Record Key: 44e1f1cd-5de0-4469-b07f-48ae2d997290
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Implantable Miniature Telescope (IMT™ by Dr. Isaac Lipshitz)
• Version Model Number: WA 2.2X
• Catalog Number: PR00018-00
• Company DUNS: 532007614
• Company Name: VISIONCARE OPHTHALMIC TECHNOLOGIES LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 408 872 9393
• Email: order@visioncareinc.net
• Phone: 408 872 9393
• Email: order@visioncareinc.net
• Phone: 408 872 9393
• Email: order@visioncareinc.net
• Phone: 408 872 9393
• Email: order@visioncareinc.net
• Phone: 408 872 9393
• Email: order@visioncareinc.net
• Phone: 408 872 9393
• Email: order@visioncareinc.net
• Phone: 408 872 9393
• Email: order@visioncareinc.net
• Phone: 408 872 9393
• Email: order@visioncareinc.net
• Phone: 408 872 9393
• Email: order@visioncareinc.net
• Phone: 408 872 9393
• Email: order@visioncareinc.net
• Phone: 408 872 9393
• Email: order@visioncareinc.net
• Phone: 408 872 9393
• Email: order@visioncareinc.net

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 50.66 KiloPascal and 121.59 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50.66 KiloPascal and 121.59 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50.66 KiloPascal and 121.59 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50.66 KiloPascal and 121.59 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50.66 KiloPascal and 121.59 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50.66 KiloPascal and 121.59 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50.66 KiloPascal and 121.59 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50.66 KiloPascal and 121.59 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50.66 KiloPascal and 121.59 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50.66 KiloPascal and 121.59 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50.66 KiloPascal and 121.59 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50.66 KiloPascal and 121.59 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M687PR00018000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P050034

FDA Product Code

• NCJ: Telescope, Implantable, Miniature

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-07-08
• Device Publish Date: 2014-09-18

On-Brand Devices [Implantable Miniature Telescope (IMT™ by Dr. Isaac Lipshitz)]

• M687PR00020000: WA 2.7X
• M687PR00018000: WA 2.2X