Adapter plate for ZEISS RESIGHT for BIOM 5m/ BIOM 5ml/BIOM ready

GUDID 04049584020161

Adapter plate for ZEISS RESIGHT for BIOM 5m/ BIOM 5ml/BIOM ready

OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung

Ophthalmic surgical microscope

• Primary Device ID: 04049584020161
• NIH Device Record Key: 95b8d306-2286-41ce-a98e-725fee027f99
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Adapter plate for ZEISS RESIGHT for BIOM 5m/ BIOM 5ml/BIOM ready
• Version Model Number: 55432
• Company DUNS: 317138956
• Company Name: OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
• 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: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	04049584020161 [Primary]

FDA Product Code

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

Sterilization

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

[04049584020161]

Moist Heat or Steam Sterilization

[04049584020161]

Moist Heat or Steam Sterilization

[04049584020161]

Moist Heat or Steam Sterilization

[04049584020161]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-15
• Device Publish Date: 2022-12-07

Devices Manufactured by OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung

• 04049584029447 - BIOM ready+ 175, for f=175 mm: 2024-09-19 BIOM ready+ 175, for f=175 mm
• 04049584029454 - BIOM ready+ 200, for f=200 mm: 2024-09-19 BIOM ready+ 200, for f=200 mm
• 04049584001450 - BK 1/W, coated, wall version, trial lens case: 2024-09-12 BK 1/W, coated, wall version, trial lens case
• 04049584001467 - BK 1/W, without convex cylinders, wall version, trial lens case: 2024-09-12 BK 1/W, without convex cylinders, wall version, trial lens case
• 04049584001474 - BK 1/W, without convex cylinders, coated, wall version, trial lens case: 2024-09-12 BK 1/W, without convex cylinders, coated, wall version, trial lens case
• 04049584001498 - BK 2, coated, wooden case with handle: 2024-09-12 BK 2, coated, wooden case with handle
• 04049584001511 - BK 2, without convex cylinders, wooden case with handle: 2024-09-12 BK 2, without convex cylinders, wooden case with handle
• 04049584001528 - BK 2, without convex cylinders, coated,wooden case with handle: 2024-09-12 BK 2, without convex cylinders, coated,wooden case with handle