Duns Number:316957240
Device Description: Video adapter "AR-T12EA", eyepiece cup, autoclavable, with pin
Catalog Number
WA97051A
Brand Name
Olympus
Version/Model Number
WA97051A
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 01, 2020
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
K951354,K944072,K950076
Product Code
EOB
Product Code Name
Nasopharyngoscope (Flexible Or Rigid)
Public Device Record Key
ccc43ae3-7120-4086-ba66-6261341eb316
Public Version Date
August 15, 2022
Public Version Number
6
DI Record Publish Date
September 21, 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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 1 |
2 | A medical device with a moderate to high risk that requires special controls. | 1109 |