Duns Number:116722111
Device Description: A stainless steel sizing guide used to verify the desired length of the implant radiograph A stainless steel sizing guide used to verify the desired length of the implant radiographically
Catalog Number
EXINS14100
Brand Name
INnate Implant Sizer
Version/Model Number
EXINS14100
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HTJ
Product Code Name
Gauge, Depth
Public Device Record Key
c3aa90c9-89a9-423e-85c9-ab8e21c6ae07
Public Version Date
August 16, 2021
Public Version Number
4
DI Record Publish Date
April 09, 2018
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 | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 44 |