Duns Number:324331826
Device Description: Device Name: IngeniOS HAIndications for Use:Oral-maxillofacial surgery, dentistry, implant
Catalog Number
1x0.5cc
Brand Name
IngeniOS HA
Version/Model Number
0.25-1mm
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 30, 2019
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
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
K102872
Product Code
LYC
Product Code Name
Bone Grafting Material, Synthetic
Public Device Record Key
742eb568-bc33-4409-88c7-9356b779ca45
Public Version Date
October 31, 2019
Public Version Number
4
DI Record Publish Date
October 24, 2017
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 58 |