Duns Number:042823948
Device Description: Gianturco-Roehm Bird's Nest Vena Cava Filter
Catalog Number
BNF-75
Brand Name
Gianturco-Roehm Bird's Nest
Version/Model Number
G50686
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
Yes
Device labeled as "Not made with natural rubber latex"
-
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
DTK
Product Code Name
FILTER, INTRAVASCULAR, CARDIOVASCULAR
Public Device Record Key
45f304c9-d3eb-474d-abb6-5b9e3e5b4815
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 24, 2015
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 | 669 |
2 | A medical device with a moderate to high risk that requires special controls. | 8328 |
3 | A medical device with high risk that requires premarket approval | 370 |
U | Unclassified | 242 |