Duns Number:116722111
Device Description: INnate Sterile Instrument KitThe kit contains two guide wires, one cannulated drill, and o INnate Sterile Instrument KitThe kit contains two guide wires, one cannulated drill, and one cannulated driver.
Catalog Number
EXINN914500
Brand Name
INnate Instrument Kit
Version/Model Number
EXINN914500
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
-
Product Code
HTJ
Product Code Name
Gauge, Depth
Public Device Record Key
e1f8e24f-3d5d-4051-830c-8f9f12006519
Public Version Date
November 23, 2021
Public Version Number
7
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 |