Duns Number:738574953
Device Description: Ophthalmic Ultrasound System: A/B Scan and PachymetryThe QUANTEL MEDICAL COMPACT TOUCH Oph Ophthalmic Ultrasound System: A/B Scan and PachymetryThe QUANTEL MEDICAL COMPACT TOUCH Ophthalmic Ultrasound System and the probes that are used with it are indicated for diagnostic imaging and biometric measurement of the eye including:• Visualization of the interior of the eye and the orbit by A and B scans.• Axial Length measurement of the eye by ultrasonic means.• Implanted IOL power calculation, using the Axial Length measurement.• Measurement of corneal thickness by ultrasonic means.
Catalog Number
-
Brand Name
COMPACT TOUCH
Version/Model Number
COMPACT TOUCH
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
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Device labeled as "Not made with natural rubber latex"
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For Single-Use
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Prescription Use (Rx)
-
Over the Counter (OTC)
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Kit
-
Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
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FDA Premarket Submission
-
Product Code
ITX
Product Code Name
Transducer, Ultrasonic, Diagnostic
Public Device Record Key
2742c06c-0c04-4135-b66b-0fa7f9126ba5
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 23, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 55 |