plusoptiX 16 S16

GUDID 04260184514212

The plusoptiX 16 is a hand held autorefractor and measures refractive data, pupil size, pupil distance and gaze deviation in real time. Both eyes are measured at the same time (binocular) at a distance of one meter (3.3 ft) to the patient eyes.

Plusoptix GmbH

External ocular measurement camera

• Primary Device ID: 04260184514212
• NIH Device Record Key: 6a08c565-fcc8-4817-8b51-41ff50b5b3b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: plusoptiX 16
• Version Model Number: S16
• Catalog Number: S16
• Company DUNS: 332755078
• Company Name: Plusoptix GmbH
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260184514212 [Primary]
GS1	04260184514229 [Package]; Package: [2 Units]; In Commercial Distribution

FDA Product Code

• HKO: Refractometer, Ophthalmic

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: 2022-10-28
• Device Publish Date: 2022-10-20

On-Brand Devices [plusoptiX 16]

• 04260184514212: The plusoptiX 16 is a hand held autorefractor and measures refractive data, pupil size, pupil di
• 04260184514113: The plusoptiX 16 is a hand held autorefractor and measures refractive data, pupil size, pupil di