Duns Number:058701385
Device Description: GrabHold™ STONE BASKET 2.2FR 4WIRE 120CM NITINOL- TIPLESS
Catalog Number
-
Brand Name
MF-Bas-2.2F-4W-120CM-NTL
Version/Model Number
MF-Bas-2.2F-4W-120CM-NTL
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
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
FFL
Product Code Name
Dislodger, Stone, Basket, Ureteral, Metal
Public Device Record Key
76d0e659-90d0-4b64-8e6d-ecbf02038283
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
February 22, 2018
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. | 63 |