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
IPN925137
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
K940079,K940079,K940079
Product Code
DYB
Product Code Name
Introducer, catheter
Public Device Record Key
8551766d-1e31-44c9-a34a-443c686fc5a0
Public Version Date
June 16, 2022
Public Version Number
1
DI Record Publish Date
June 08, 2022
Package DI Number
20801902210955
Quantity per Package
25
Contains DI Package
10801902210958
Package Discontinue Date
-
Package Status
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 |