Duns Number:942192550
Device Description: ARTHROSCOPEIntended use of MediVision Arthroscope is for orthopedic use in the knee, shoul ARTHROSCOPEIntended use of MediVision Arthroscope is for orthopedic use in the knee, shoulder, wrist (carpal ligament release), temporal-mandibular joint, ankle, elbow, and plantar fascia release.SINUSCOPEIntended use of MediVision Sinuscope is to allow direct visualization (through the Sinuscope or the video monitor) of the nasal cavity.
Catalog Number
MVA430
Brand Name
MediVision
Version/Model Number
MVA430
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
EOB
Product Code Name
Nasopharyngoscope (Flexible Or Rigid)
Public Device Record Key
c9b2ba4a-eaed-4070-bc1d-46484cfa3240
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
December 07, 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. | 25 |