Duns Number:057728685
Device Description: Matrix strips, 4 in x 0.375 in / 10 cm x 0.95 cm
Catalog Number
-
Brand Name
Matrix Strips
Version/Model Number
KSTRIP1000
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
Yes
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
EKF
Product Code Name
INSTRUMENT, CONTOURING, MATRIX, OPERATIVE
Public Device Record Key
ad49327d-bcff-4ae0-a180-a2f43cbab353
Public Version Date
August 29, 2022
Public Version Number
1
DI Record Publish Date
August 19, 2022
Package DI Number
50732224003516
Quantity per Package
12
Contains DI Package
30732224003512
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 33 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 25 |