Duns Number:079699357
Device Description: Medfix® Lumbar Curette Size 6/0, 13 3/4" (349mm) Angled, Red Aluminum Handle
Catalog Number
-
Brand Name
Medfix
Version/Model Number
MF-9012
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
-
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
FZS
Product Code Name
CURETTE, SURGICAL, GENERAL USE
Public Device Record Key
ff035877-36bf-4712-b762-7c00b63b35ad
Public Version Date
April 13, 2020
Public Version Number
1
DI Record Publish Date
April 03, 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 | 998 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |