Duns Number:130789944
Device Description: Nitinol Stone Retrieval Basket 2.2Fr, 120cm, Tipless
Catalog Number
BEZ22120
Brand Name
Dornier MedTech
Version/Model Number
2.2Fr x 120cm, Tipless Basket
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FGO
Product Code Name
Dislodger, Stone, Flexible
Public Device Record Key
9442d27e-908a-4957-a7cf-775f3569a047
Public Version Date
February 26, 2020
Public Version Number
1
DI Record Publish Date
February 18, 2020
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 | 28 |
2 | A medical device with a moderate to high risk that requires special controls. | 101 |