Duns Number:030479000
Device Description: STABILINER QUICK SET INTRO KIT 1 CART AND 20 BROWN MIXERS 10 KITS PER CASE
Catalog Number
CD001
Brand Name
STABILINER
Version/Model Number
CD001
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
EMA
Product Code Name
Cement, Dental
Public Device Record Key
e9be7200-88ce-489f-a004-690653fe8b2a
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 03, 2016
Package DI Number
10866738000203
Quantity per Package
1
Contains DI Package
00866738000206
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
KIT
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 15 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 46 |