Single-use lenses for RESIGHT, MACULA LENS

GUDID 04049539106704

Single- use lenses for RESIGHT are ophthalmic surgical microscope lenses used in combination with the ZEISS RESIGHT fundus viewing system. The fundus viewing system is an accessory for surgical microscopes which is used for surgery on the posterior segment of the eye. It is used for stereoscopic imaging of the posterior segment and the retina.

Carl Zeiss Meditec AG

Ophthalmic surgical microscope lens

• Primary Device ID: 04049539106704
• NIH Device Record Key: 52bb14f7-2bd8-48c3-b216-60a200e6c016
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Single-use lenses for RESIGHT, MACULA LENS
• Version Model Number: 302721-9107-000
• Company DUNS: 342228620
• Company Name: Carl Zeiss Meditec AG
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Device Dimensions

• Width: 23 Millimeter
• Height: 24 Millimeter
• Length: 40 Millimeter
• Width: 23 Millimeter
• Height: 24 Millimeter
• Length: 40 Millimeter
• Width: 23 Millimeter
• Height: 24 Millimeter
• Length: 40 Millimeter
• Width: 23 Millimeter
• Height: 24 Millimeter
• Length: 40 Millimeter
• Width: 23 Millimeter
• Height: 24 Millimeter
• Length: 40 Millimeter
• Width: 23 Millimeter
• Height: 24 Millimeter
• Length: 40 Millimeter
• Width: 23 Millimeter
• Height: 24 Millimeter
• Length: 40 Millimeter
• Width: 23 Millimeter
• Height: 24 Millimeter
• Length: 40 Millimeter
• Width: 23 Millimeter
• Height: 24 Millimeter
• Length: 40 Millimeter
• Width: 23 Millimeter
• Height: 24 Millimeter
• Length: 40 Millimeter
• Width: 23 Millimeter
• Height: 24 Millimeter
• Length: 40 Millimeter
• Width: 23 Millimeter
• Height: 24 Millimeter
• Length: 40 Millimeter
• Width: 23 Millimeter
• Height: 24 Millimeter
• Length: 40 Millimeter
• Width: 23 Millimeter
• Height: 24 Millimeter
• Length: 40 Millimeter
• Width: 23 Millimeter
• Height: 24 Millimeter
• Length: 40 Millimeter
• Width: 23 Millimeter
• Height: 24 Millimeter
• Length: 40 Millimeter
• Width: 23 Millimeter
• Height: 24 Millimeter
• Length: 40 Millimeter

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The product must be stored in a dry environment shielded from direct sunlight and within a temperature range of +10 °C to +35 °C.
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The product must be stored in a dry environment shielded from direct sunlight and within a temperature range of +10 °C to +35 °C.
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The product must be stored in a dry environment shielded from direct sunlight and within a temperature range of +10 °C to +35 °C.
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The product must be stored in a dry environment shielded from direct sunlight and within a temperature range of +10 °C to +35 °C.
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The product must be stored in a dry environment shielded from direct sunlight and within a temperature range of +10 °C to +35 °C.
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The product must be stored in a dry environment shielded from direct sunlight and within a temperature range of +10 °C to +35 °C.
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The product must be stored in a dry environment shielded from direct sunlight and within a temperature range of +10 °C to +35 °C.
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The product must be stored in a dry environment shielded from direct sunlight and within a temperature range of +10 °C to +35 °C.
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The product must be stored in a dry environment shielded from direct sunlight and within a temperature range of +10 °C to +35 °C.
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The product must be stored in a dry environment shielded from direct sunlight and within a temperature range of +10 °C to +35 °C.
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The product must be stored in a dry environment shielded from direct sunlight and within a temperature range of +10 °C to +35 °C.
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The product must be stored in a dry environment shielded from direct sunlight and within a temperature range of +10 °C to +35 °C.
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The product must be stored in a dry environment shielded from direct sunlight and within a temperature range of +10 °C to +35 °C.
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The product must be stored in a dry environment shielded from direct sunlight and within a temperature range of +10 °C to +35 °C.
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The product must be stored in a dry environment shielded from direct sunlight and within a temperature range of +10 °C to +35 °C.
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The product must be stored in a dry environment shielded from direct sunlight and within a temperature range of +10 °C to +35 °C.
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The product must be stored in a dry environment shielded from direct sunlight and within a temperature range of +10 °C to +35 °C.

Device Identifiers

Device Issuing Agency	Device ID
GS1	04049539106704 [Primary]
GS1	04049539106711 [Package]; Package: dispenser [12 Units]; In Commercial Distribution

FDA Product Code

• HRM: Microscope, Operating & Accessories, Ac-Powered, Ophthalmic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-15
• Device Publish Date: 2024-11-07

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