Duns Number:830350380
Device Description: TENT SCREW 7000016 1.2 MM X 12 MM (4/PK)
Catalog Number
-
Brand Name
ARTISAN™ SPACE MAINTENANCE SYSTEM
Version/Model Number
7000016
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K100779,K100779
Product Code
DZE
Product Code Name
IMPLANT, ENDOSSEOUS, ROOT-FORM
Public Device Record Key
0e0699a1-0528-4781-910c-12e3359d9cd7
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 15, 2015
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 | 13352 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 26085 |
| 3 | A medical device with high risk that requires premarket approval | 190 |
| U | Unclassified | 75 |