Duns Number:315304071
Device Description: URETERORENOSCOPE 5° 6.5/8.5FR WL 330MM semi-rigid, with straight ocular lens, working cha URETERORENOSCOPE 5° 6.5/8.5FR WL 330MM semi-rigid, with straight ocular lens, working channel 1: 1x4 (2x2.2)Fr, working channel 2: 2.4Fr, atraumatic distal tip, TL 473mm, fiber image carrier, reusable
Catalog Number
8708.517
Brand Name
E-LINE
Version/Model Number
8708517
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FGB
Product Code Name
Ureteroscope and accessories, flexible/rigid
Public Device Record Key
344ffbaf-239f-4e6f-be42-de4ad9b879f5
Public Version Date
April 27, 2021
Public Version Number
6
DI Record Publish Date
February 14, 2017
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 | 587 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1835 |