Duns Number:002348191
Device Description: Spring-Wire Guide
Catalog Number
AW-04018
Brand Name
ARROW
Version/Model Number
IPN037337
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 05, 2016
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
K810675,K810675,K810675
Product Code
DQX
Product Code Name
WIRE, GUIDE, CATHETER
Public Device Record Key
144d4ae1-7088-4a08-9024-4c894e7f57b7
Public Version Date
December 22, 2021
Public Version Number
4
DI Record Publish Date
September 16, 2016
Package DI Number
40801906122869
Quantity per Package
1
Contains DI Package
30801905122863
Package Discontinue Date
October 05, 2016
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 |