Duns Number:078352849
Device Description: Goldman-Fox Scissors are designed for contouring and cutting gingival tissue. They are als Goldman-Fox Scissors are designed for contouring and cutting gingival tissue. They are also used to trim tissue, barriers and granulation tissue on the underside of flaps or cut suture thread during surgery.
Catalog Number
Scissors GFox Straight
Brand Name
Scissors -Goldman Fox type
Version/Model Number
Scissors GFox Straight
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DZN
Product Code Name
Instruments, Dental Hand
Public Device Record Key
d9319ed0-b587-447d-9875-6dce99df4f08
Public Version Date
February 11, 2021
Public Version Number
1
DI Record Publish Date
February 03, 2021
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 | 405 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 536 |