Duns Number:058701385
Device Description: GrabHold(TM) STONE BASKET 2.2FR 4WIRE 120CM NITINOL- TIPLESS-FLEXIBLE
Catalog Number
-
Brand Name
MF-Bas-2.2F-4W-120CM-NTL-F
Version/Model Number
MF-Bas-2.2F-4W-120CM-NTL-F
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
dbdc3181-3487-4206-9e9e-2eb477304a06
Public Version Date
April 02, 2018
Public Version Number
1
DI Record Publish Date
March 01, 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 |