Duns Number:002348191
Device Description: FlexTip Plus(R) Epidural Catheterization Kit
Catalog Number
MTO-05500-SU
Brand Name
ARROW
Version/Model Number
IPN046838
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
-
Product Code
OGE
Product Code Name
Epidural anesthesia kit
Public Device Record Key
ec9c5c31-79f9-4dd6-af52-d6d555ffefb6
Public Version Date
May 06, 2021
Public Version Number
6
DI Record Publish Date
April 02, 2019
Package DI Number
60801902128432
Quantity per Package
5
Contains DI Package
50801902128435
Package Discontinue Date
May 05, 2021
Package Status
Not in Commercial Distribution
Package Type
Case
| 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 |