Duns Number:316957240
Device Description: Telescope "OES ELITE", 4 mm, 0°, HD, autoclavable
Catalog Number
WA2T400A
Brand Name
Olympus
Version/Model Number
WA2T400A
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
K151191
Product Code
FGC
Product Code Name
Urethroscope
Public Device Record Key
8004f959-d592-4f64-ac3a-b2388a9c28a5
Public Version Date
October 12, 2018
Public Version Number
4
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 |