Pentacam AXL Wave

GUDID 04049584025357

While rotating around the eye, the Pentacam AXL Wave captures Scheimpflug images of the anterior eye segment through varying axes to evaluate several parameters of the cornea, pupil, anterior chamber and lens. The axial length of the eye is measured and displayed by interferometry. Wavefront measurement uses a Hartmann Shack aberrometer to detect the low and high order aberrations of the entire eye.

OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung

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• Primary Device ID: 04049584025357
• NIH Device Record Key: 84db981e-f343-47bc-8732-6690f24eb8aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pentacam AXL Wave
• Version Model Number: 70020
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04049584025357 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201724

FDA Product Code

• MXK: Device, Analysis, Anterior Segment

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-11-11
• Device Publish Date: 2021-11-03

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