Duns Number:530269083
Device Description: Double color handle，hexagonal，3 * 3 wire,Diameter is 15 mm,outer diameter is 7Fr,working Double color handle，hexagonal，3 * 3 wire,Diameter is 15 mm,outer diameter is 7Fr,working length is 2300mm
Catalog Number
NPFS01-11523230
Brand Name
NA
Version/Model Number
NPFS01-11523230
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
FDI
Product Code Name
Snare, Flexible
Public Device Record Key
0abee0d3-eb9f-49bc-9007-b2a9bda1d2be
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
April 06, 2016
Package DI Number
26932503552015
Quantity per Package
10
Contains DI Package
16932503552018
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 142 |