Distancing plate for Möller-Wedel adapter for BIOM

GUDID 04049584008626

Distancing plate for Möller-Wedel adapter for BIOM

OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung

Ophthalmic surgical microscope

• Primary Device ID: 04049584008626
• NIH Device Record Key: c38ef041-e763-4cb6-ad9a-b060d80cf303
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Distancing plate for Möller-Wedel adapter for BIOM
• Version Model Number: 54639
• 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: false
• Serial Number: false
• Manufacturing Date: false
• 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	04049584008626 [Primary]

FDA Product Code

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

Sterilization

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

[04049584008626]

Moist Heat or Steam Sterilization

[04049584008626]

Moist Heat or Steam Sterilization

[04049584008626]

Moist Heat or Steam Sterilization

[04049584008626]

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