Duns Number:876570990
Device Description: Freer Septum Elev, dbl..end, 4.5mm, 7 1/2"
Catalog Number
-
Brand Name
Freer Septum Elevator Double
Version/Model Number
62-474000
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
-
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
GEG
Product Code Name
Elevator, Surgical, General & Plastic Surgery
Public Device Record Key
0d996587-43c8-4e98-9de6-e789fa9a04eb
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
March 28, 2022
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 | 120 |