Duns Number:544427443
Device Description: This instrument has been designed to be used with endo-therapy accessories such as a biops This instrument has been designed to be used with endo-therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within urinary tract and interior of the kidney.
Catalog Number
-
Brand Name
Uscope
Version/Model Number
UE3011
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K171076,K171076,K171076
Product Code
FGB
Product Code Name
Ureteroscope And Accessories, Flexible/Rigid
Public Device Record Key
97999be1-1c97-4024-8f11-9f498521f53d
Public Version Date
January 23, 2019
Public Version Number
4
DI Record Publish Date
August 08, 2017
Package DI Number
16971176280033
Quantity per Package
1
Contains DI Package
06971176280036
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |