Duns Number:002348191
Device Description: Spring-Wire Guide .018" (0.46 mm) diameter x 17-3/4" (45 cm) wire / Proximal End: Solid Wi Spring-Wire Guide .018" (0.46 mm) diameter x 17-3/4" (45 cm) wire / Proximal End: Solid Wire .018" diameter / Distal End: Coil .018" diameter x 9 cm
Catalog Number
PW-18045
Brand Name
ARROW
Version/Model Number
IPN033565
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
K011084,K011084
Product Code
DQX
Product Code Name
WIRE, GUIDE, CATHETER
Public Device Record Key
62956198-62d7-45fb-86d0-6c9e78755210
Public Version Date
December 22, 2021
Public Version Number
11
DI Record Publish Date
September 16, 2016
Package DI Number
30801902013195
Quantity per Package
5
Contains DI Package
00801902013194
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 |