Duns Number:078273228
Device Description: Golden-Taper Rotary Assorted Pack- SX, S1, S2, F1, F2 & F3 (6 files) - Length 31mm
Catalog Number
GTAK-31
Brand Name
GoldenDent
Version/Model Number
GTAK-31
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EKS
Product Code Name
FILE, PULP CANAL, ENDODONTIC
Public Device Record Key
beef5622-0947-47bb-9ac2-20d4deed7696
Public Version Date
March 05, 2021
Public Version Number
1
DI Record Publish Date
February 25, 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 | 145 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |