Duns Number:316957240
Device Description: Ureteroscope, 6,4/7,8 Fr. x 430 mm, 7°, 4,2 Fr. channel, with WA00395A
Catalog Number
WA29040A
Brand Name
Olympus
Version/Model Number
WA29040A
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 31, 2022
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
K951855
Product Code
FGB
Product Code Name
Ureteroscope And Accessories, Flexible/Rigid
Public Device Record Key
1cba763c-4bf6-468f-bcac-688bc691572f
Public Version Date
May 13, 2022
Public Version Number
5
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 |