Duns Number:073503117
Device Description: KeySplint Soft Clear for Carbon 0.5 kg sample
Catalog Number
4200155
Brand Name
KeyPrint
Version/Model Number
4200155
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
KMY
Product Code Name
POSITIONER, TOOTH, PREFORMED
Public Device Record Key
0ff266f1-e3c9-49d5-ae70-72fb4f098201
Public Version Date
November 10, 2021
Public Version Number
3
DI Record Publish Date
December 20, 2019
Package DI Number
H66842001552
Quantity per Package
8
Contains DI Package
H66842001551
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 290 |