Duns Number:738574953
Device Description: 15 MHz Probe for eye and orbit examination. Automatic biometry readings obtained from a B 15 MHz Probe for eye and orbit examination. Automatic biometry readings obtained from a B mode image allowing axial length measurements for difficult to mesure long eyes or posterior staphyloma.
Catalog Number
-
Brand Name
B Probe 15MHz COMPACT TOUCH
Version/Model Number
B1 COMPACT TOUCH 2017
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"
-
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
K180265
Product Code
ITX
Product Code Name
Transducer, Ultrasonic, Diagnostic
Public Device Record Key
45c736ed-f4b3-4a50-82cf-e53f6197f5df
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
April 13, 2018
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 |