Duns Number:078273228
Device Description: WagoTrix Sectional Matrix System Intro Kit includes: 3.5 Anatomical Matrix Refill - Qty 25 WagoTrix Sectional Matrix System Intro Kit includes: 3.5 Anatomical Matrix Refill - Qty 25, 4.5 Anatomical Matrix Refill - Qty 25, 5.5 Anatomical Matrix Refill - Qty 25, 6.5 Anatomical Matrix Refill - Qty 25, Wedge - Small - Qty 25, Wedge - Medium - Qty 25, Wedge - Large - Qty 25, Matrix Ring Universal - Qty 35, Matrix Pin Holder - Qty 1, Matrix Ring Forceps - Qty 1
Catalog Number
WGSMIK
Brand Name
Wagotrix
Version/Model Number
WGSMIK
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
DZN
Product Code Name
INSTRUMENTS, DENTAL HAND
Public Device Record Key
c941c474-d771-40de-bafd-de69c89c2911
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 |