Duns Number:401020409
Device Description: Ureteral catheter, L. 80cm curved open, without eye, 07 CH/Fr
Catalog Number
OLCAC07
Brand Name
OlyCath Curved 0 Eye 7 French
Version/Model Number
ROTH7000ST245
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
-
Product Code
EYB
Product Code Name
Catheter, Ureteral, Gastro-Urology
Public Device Record Key
86d5aa0c-01b0-4459-9d25-0ffe1f4f5b0d
Public Version Date
May 14, 2020
Public Version Number
1
DI Record Publish Date
May 06, 2020
Package DI Number
03700512977995
Quantity per Package
10
Contains DI Package
03700512967996
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box 1
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 64 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 152 |