Duns Number:002348191
Device Description: Manual Needle Set
Catalog Number
9094
Brand Name
ARROW
Version/Model Number
IPN055711
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
4ba8f359-62aa-480a-9bea-86af694d4a7c
Public Version Date
March 07, 2022
Public Version Number
2
DI Record Publish Date
April 30, 2020
Package DI Number
20801902158233
Quantity per Package
6
Contains DI Package
10801902158236
Package Discontinue Date
March 04, 2022
Package Status
Not in Commercial Distribution
Package Type
Box
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 |