Duns Number:002348191
Device Description: Nitinol Marked Spring-Wire Guide with Arrow(R) GlideWheel(TM) Wire Advancer Maximum OD per Nitinol Marked Spring-Wire Guide with Arrow(R) GlideWheel(TM) Wire Advancer Maximum OD per ISO 11070 is 0.89 mm.
Catalog Number
AW-04200-N
Brand Name
ARROW
Version/Model Number
IPN920873
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
DQX
Product Code Name
Wire, guide, catheter
Public Device Record Key
e31d7191-0edb-43e3-aebe-cbeada97282f
Public Version Date
June 21, 2022
Public Version Number
1
DI Record Publish Date
June 13, 2022
Package DI Number
30801902198878
Quantity per Package
1
Contains DI Package
20801902198871
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 |