Duns Number:315304071
Device Description: CYSTOSCOPE 5° 4.5/6.5FR WL 120MM rigid, with lateral ocular lens, working channel for ins CYSTOSCOPE 5° 4.5/6.5FR WL 120MM rigid, with lateral ocular lens, working channel for instruments up to 3Fr, atraumatic distal tip, TL 247mm, fiber image carrier
Catalog Number
8715401
Brand Name
E-LINE
Version/Model Number
8715401
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
82b43019-c2a5-44d8-8211-455f229fc233
Public Version Date
April 28, 2021
Public Version Number
3
DI Record Publish Date
September 23, 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 | 587 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1835 |