Duns Number:118492643
Device Description: T.A.L.O.N. 7-Site I.O. Starter SetT.A.L.O.N. IO Needle Set 1 eaEZ-Stabilize T.A.L.O.N. 7-Site I.O. Starter SetT.A.L.O.N. IO Needle Set 1 eaEZ-Stabilizer 1 eaSaline Flush (5cc pre-filled syringe) 1 eaPovidone Prep Pad 2 eaAlcohol Prep Pad 2 eaT.A.L.O.N. IFU 1 eaEZ-Stabilizer IFU 1 ea
Catalog Number
80-081
Brand Name
T.A.L.O.N. 7-Site I.O. Starter Kit
Version/Model Number
03
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"
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
bcc60824-96ba-4297-a12b-b283bfee6cda
Public Version Date
April 12, 2022
Public Version Number
2
DI Record Publish Date
April 03, 2020
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 |