Duns Number:968903703
Device Description: GW WWFS35300 WHOLEY WIRE V03
Catalog Number
-
Brand Name
Wholey™
Version/Model Number
WWFS35300
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"
-
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
K120863,K120863
Product Code
DQX
Product Code Name
Wire, guide, catheter
Public Device Record Key
3f54236b-72b5-45ea-9341-9932f84f9046
Public Version Date
December 22, 2021
Public Version Number
5
DI Record Publish Date
June 16, 2017
Package DI Number
00821684065907
Quantity per Package
3
Contains DI Package
00821684058633
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PK
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |