Pentacam HR

GUDID 04049584000026

The Pentacam Scheimpflug Camera is a non-invasive, diagnostic system created to take photographs of the anterior segment of the eye, table mounted and

OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung

Corneal topography system

• Primary Device ID: 04049584000026
• NIH Device Record Key: 1a5dbe42-41c8-41ef-810f-eb604660b711
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pentacam HR
• Version Model Number: 70900
• Company DUNS: 317138956
• Company Name: OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Height: 535 Millimeter
• Depth: 360 Millimeter
• Width: 280 Millimeter
• Weight: 11 Kilogram

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
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	04049584000026 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030719

FDA Product Code

• MXK: Device,Analysis,Anterior Segment

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-01

Devices Manufactured by OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung

• 04049584005878 - Lorgnette with striated lenses (Bagolini), Axes 45°/123°: 2023-06-26
• 04049584032454 - Lidstick: 2023-06-26
• 04049584033048 - GONIO ready® 200 for f=200: 2023-04-04 GONIO ready® 200 for f=200
• 04049584034489 - GONIO ready® 175 for f=175: 2023-04-04 GONIO ready® 175 for f=175
• 04049584001030 - BK X/O (according to Kochniss), without convex cylinders, coated, inclusive tria: 2022-12-15 BK X/O (according to Kochniss), without convex cylinders, coated, inclusive trial lens case
• 04049584001078 - Prism Lens Case, coated: 2022-12-15 Prism Lens Case, coated
• 04049584001153 - Prism Lens Case S, coated: 2022-12-15 Prism Lens Case S, coated
• 04049584001191 - BK 1/T, table version, trial lens case: 2022-12-15 BK 1/T, table version, trial lens case