Duns Number:040729840
Device Description: GOLDMAN-FOX ANTERIOR CURETTE #2 DOUBLE ENDED OPEN BLADE CURVE MEDIUM CONTRA-ANGLE ROUND TO GOLDMAN-FOX ANTERIOR CURETTE #2 DOUBLE ENDED OPEN BLADE CURVE MEDIUM CONTRA-ANGLE ROUND TOE RIGID SHANK
Catalog Number
1102-SCGF2
Brand Name
GOLDMAN-FOX ANTERIOR CURETTE
Version/Model Number
1102-SCGF2
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
EMK
Product Code Name
CURETTE, SURGICAL, DENTAL
Public Device Record Key
84d0fce6-d27b-4451-a410-eca6d97ad719
Public Version Date
September 10, 2019
Public Version Number
3
DI Record Publish Date
September 17, 2018
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 |