Duns Number:315304071
Device Description: OBTURATOR FOR NEPHROSCOPE 18FR WL 229mm, round, cannulated, rounded distal end, compatibl OBTURATOR FOR NEPHROSCOPE 18FR WL 229mm, round, cannulated, rounded distal end, compatible with sheath 8968011, reusable
Catalog Number
8968.111
Brand Name
NA
Version/Model Number
8968111
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
FEC
Product Code Name
OBTURATOR, FOR ENDOSCOPE
Public Device Record Key
9cc0e811-fb3d-4832-859b-8274540245a6
Public Version Date
April 28, 2021
Public Version Number
6
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 |