Duns Number:002348191
Device Description: DuoFlex(R) Spring-Wire Guide Maximum OD per ISO 11070 is 0.82 mm.
Catalog Number
AW-04032
Brand Name
ARROW
Version/Model Number
IPN035364
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
K914531,K914531,K914531
Product Code
DQX
Product Code Name
WIRE, GUIDE, CATHETER
Public Device Record Key
ed529a5b-cc6e-4cd6-adf4-f5cd5e03107e
Public Version Date
March 23, 2022
Public Version Number
9
DI Record Publish Date
September 16, 2016
Package DI Number
30801902007330
Quantity per Package
1
Contains DI Package
20801902007333
Package Discontinue Date
-
Package Status
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 |