Duns Number:002348191
Device Description: FASTTACTICAL STERNAL IO DEV STERILE
Catalog Number
FASTT
Brand Name
ARROW
Version/Model Number
IPN038253
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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"
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
K130487,K130487
Product Code
FMI
Product Code Name
Needle, hypodermic, single lumen
Public Device Record Key
77d68adf-a24a-4c26-a7a8-0255943e8dc1
Public Version Date
October 16, 2018
Public Version Number
1
DI Record Publish Date
September 15, 2018
Package DI Number
34026704628699
Quantity per Package
10
Contains DI Package
14026704628695
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Multipack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |