Duns Number:433815198
Device Description: TRANSFER SCREW M2 H15 MM PRE-KOH D.4.25/5.00 MM
Catalog Number
VTRA2-200-15
Brand Name
TRANSFER SCREW M2 H15 MM
Version/Model Number
VTRA2-200-15
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
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
K142242
Product Code
NHA
Product Code Name
Abutment, Implant, Dental, Endosseous
Public Device Record Key
2ebd23f1-8a14-4783-b7a3-a131b66e40f8
Public Version Date
November 08, 2019
Public Version Number
5
DI Record Publish Date
September 23, 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 | 1248 |
2 | A medical device with a moderate to high risk that requires special controls. | 1062 |