Duns Number:738574953
Device Description: Axial length measurement probe with an integrated laser pointer for biometry:- Ensuring th Axial length measurement probe with an integrated laser pointer for biometry:- Ensuring the acquisition in the visual axis- Increasing the patient cooperation- Accelerating the speed of acquisition of A scans
Catalog Number
-
Brand Name
PROBEAM Biometry Probe
Version/Model Number
TP-02-las
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)
-
Device labeled as "Not made with natural rubber latex"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ITX
Product Code Name
Transducer, Ultrasonic, Diagnostic
Public Device Record Key
b56687d1-bc85-4e6b-a9ee-8e655bfa1554
Public Version Date
May 23, 2018
Public Version Number
3
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 |