Duns Number:545188828
Device Description: ODM-2200 Ultrasonic A/B Scanner for Ophthalmology is an ultrasonic imaging medical device ODM-2200 Ultrasonic A/B Scanner for Ophthalmology is an ultrasonic imaging medical device intended for ophthalmological ultrasonic diagnosis and biometric measurement.
Catalog Number
-
Brand Name
Ultrasonic A/B Scanner for Ophthalmology
Version/Model Number
ODM-2200
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
3e793704-bc7a-401f-92cd-8a15242bef43
Public Version Date
March 29, 2018
Public Version Number
2
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 |