Duns Number:118492643
Device Description: The T.A.L.O.N.™ (Tactically Advanced Lifesaving IO Needle) is the single solution for intr
Catalog Number
80-081
Brand Name
T.A.L.O.N. 7-Site I.O. Starter Kit
Version/Model Number
80-081
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
June 30, 2023
Issuing Agency
In HIBCC
MRI safety Status
MR Unsafe
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"
Yes
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
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
479a7ae5-05c4-4ec5-a710-b1d3126ce365
Public Version Date
April 12, 2022
Public Version Number
4
DI Record Publish Date
March 08, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 217 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 48 |