Duns Number:315304071
Device Description: OBTURATOR FOR NEPHROSCOPE 24FR WL 229mm, round, cannulated, rounded distal end, compatibl OBTURATOR FOR NEPHROSCOPE 24FR WL 229mm, round, cannulated, rounded distal end, compatible with sheath 8965041, reusable
Catalog Number
8965.141
Brand Name
NA
Version/Model Number
8965141
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
d783588b-9b49-4611-b3d3-ece6e2b3f162
Public Version Date
April 28, 2021
Public Version Number
2
DI Record Publish Date
March 03, 2021
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 |