Duns Number:826110710
Device Description: Retrieval Device
Catalog Number
FA-88810-40
Brand Name
Alligator
Version/Model Number
FA-88810-40
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
DQY
Product Code Name
CATHETER, PERCUTANEOUS
Public Device Record Key
a42295a8-cf30-4402-9761-eed538dccc44
Public Version Date
June 05, 2020
Public Version Number
3
DI Record Publish Date
October 12, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 1759 |
3 | A medical device with high risk that requires premarket approval | 562 |