Duns Number:030479000
Device Description: STABILINER STANDARD SET INTRO KIT 1 CART AND 10 KITS BROWN MIXERS 20 PER CASE (HS PART # STABILINER STANDARD SET INTRO KIT 1 CART AND 10 KITS BROWN MIXERS 20 PER CASE (HS PART # 9973204)
Catalog Number
CD002
Brand Name
STABILINER
Version/Model Number
CD002
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
d31e07c2-08f8-4c75-927b-8153a7bd44d1
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 03, 2016
Package DI Number
10866738000227
Quantity per Package
1
Contains DI Package
00866738000220
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 |