Duns Number:627879687
Device Description: The Uretero1 Reverse Deflection Disposable Ureteroscope is a single use flexible ureterosc The Uretero1 Reverse Deflection Disposable Ureteroscope is a single use flexible ureteroscope that is used to visualize and perform various diagnostic and therapeutic procedures in the urinary tract.
Catalog Number
URORD101
Brand Name
Uretero1
Version/Model Number
URORD101
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"
Yes
For Single-Use
Yes
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
K211347,K211347
Product Code
FGB
Product Code Name
Ureteroscope and accessories, flexible/rigid
Public Device Record Key
2691ca0f-7ea4-4bf6-a97d-b89a323f27b7
Public Version Date
June 21, 2022
Public Version Number
1
DI Record Publish Date
June 10, 2022
Package DI Number
10724995209176
Quantity per Package
5
Contains DI Package
00724995209179
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 51 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 902 |