Duns Number:545188828
Device Description: MD-1000A/P Ultrasonic Biometer for Ophthalmology is an ultrasonic measuring medical device MD-1000A/P Ultrasonic Biometer for Ophthalmology is an ultrasonic measuring medical device based on pulse reflection. It’s intended for measurements of biometric parameters and corneal thickness.
Catalog Number
-
Brand Name
Ultrasonic Biometer for Ophthalmology
Version/Model Number
MD-1000A/P
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)
Yes
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
08364347-8459-4b5a-aa45-48be52fad5d9
Public Version Date
April 25, 2018
Public Version Number
3
DI Record Publish Date
September 01, 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. | 9 |