Duns Number:040729840
Device Description: FREER SEPTUM ELEVATOR/MUCOSA KNIFE DOUBLE ENDED
Catalog Number
468-163
Brand Name
FREER SEPTUM ELEVATOR/MUCOSA KNIFE
Version/Model Number
468-163
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"
Yes
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
KAD
Product Code Name
Elevator, Ent
Public Device Record Key
613f0db6-879f-4737-8ad1-75ff54822a7e
Public Version Date
July 12, 2019
Public Version Number
5
DI Record Publish Date
January 03, 2019
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 | 10108 |
2 | A medical device with a moderate to high risk that requires special controls. | 3414 |