Duns Number:832763002
Device Description: 1.5 Fr, 120 cm, NiTi Tipless Stone Basket
Catalog Number
554120
Brand Name
Halo
Version/Model Number
554120
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
Yes
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
FFL
Product Code Name
Dislodger, Stone, Basket, Ureteral, Metal
Public Device Record Key
0d262d7f-8aaf-403c-bd46-d81a18f1d160
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
November 15, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 10 |