Wholey™
GUDID 20763000919614
GW WWSS35260 WHOLEY WIRE STND STR 260CM
EV3, INC
Peripheral vascular guidewire, manual| Primary Device ID | 20763000919614 |
| NIH Device Record Key | 64ae32ea-be57-4636-9350-e686265ea6e4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Wholey™ |
| Version Model Number | WWSS35260 |
| Company DUNS | 117446916 |
| Company Name | EV3, INC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
Device Dimensions
| Guidewire Diameter | 0.089 Centimeter |
| Guidewire Length | 260 Centimeter |
| Guidewire Diameter | 0.089 Centimeter |
| Guidewire Length | 260 Centimeter |
| Guidewire Diameter | 0.089 Centimeter |
| Guidewire Length | 260 Centimeter |
| Guidewire Diameter | 0.089 Centimeter |
| Guidewire Length | 260 Centimeter |
| Guidewire Diameter | 0.089 Centimeter |
| Guidewire Length | 260 Centimeter |
| Guidewire Diameter | 0.089 Centimeter |
| Guidewire Length | 260 Centimeter |
| Guidewire Diameter | 0.089 Centimeter |
| Guidewire Length | 260 Centimeter |
| Guidewire Diameter | 0.089 Centimeter |
| Guidewire Length | 260 Centimeter |
| Guidewire Diameter | 0.089 Centimeter |
| Guidewire Length | 260 Centimeter |
| Guidewire Diameter | 0.089 Centimeter |
| Guidewire Length | 260 Centimeter |
| Guidewire Diameter | 0.089 Centimeter |
| Guidewire Length | 260 Centimeter |
| Guidewire Diameter | 0.089 Centimeter |
| Guidewire Length | 260 Centimeter |
| Guidewire Diameter | 0.089 Centimeter |
| Guidewire Length | 260 Centimeter |
| Guidewire Diameter | 0.089 Centimeter |
| Guidewire Length | 260 Centimeter |
| Guidewire Diameter | 0.089 Centimeter |
| Guidewire Length | 260 Centimeter |
| Guidewire Diameter | 0.089 Centimeter |
| Guidewire Length | 260 Centimeter |
| Guidewire Diameter | 0.089 Centimeter |
| Guidewire Length | 260 Centimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000919610 [Primary] |
| GS1 | 20763000919614 [Package] Contains: 00763000919610 Package: PK [3 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K120863
FDA Product Code
| DQX | Wire, guide, catheter |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-06-10 |
| Device Publish Date | 2024-06-01 |
On-Brand Devices [Wholey™]
| 20763000919638 | GW WWES35001 WHOLEY WIRE EXT SYSTEM NCE |
| 20763000919621 | GW WWSS35300 WHOLEY WIRE STND STR 300CM |
| 20763000919614 | GW WWSS35260 WHOLEY WIRE STND STR 260CM |
| 20763000919607 | GW WWSS35175 WHOLEY WIRE STND STR 175CM |
| 20763000919591 | GW WWSS35145 WHOLEY WIRE STND STR 145CM |
| 20763000919584 | GW WWIJ35300 WHOLEY WIRE INT J 300CM |
| 20763000919577 | GW WWIJ35260 WHOLEY WIRE INT J 260CM |
| 20763000919560 | GW WWIJ35175 WHOLEY WIRE INT J 175CM |
| 20763000919553 | GW WWIJ35145 WHOLEY WIRE INT J 145CM |
| 20763000919546 | GW WWFS35300 WHOLEY WIRE FLOP STR 300CM |
| 20763000919539 | GW WWFS35260 WHOLEY WIRE FLOP STR 260CM |
| 20763000919522 | GW WWFS35175 WHOLEY WIRE FLOP STR 175CM |
| 20763000919515 | GW WWFS35145 WHOLEY WIRE FLOP STR 145CM |
Trademark Results [Wholey]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 WHOLEY 97000535 not registered Live/Pending |
WHOLEY LLC 2021-08-29 |
 WHOLEY 86111863 4651605 Live/Registered |
Robert Wholey & Co., Inc. 2013-11-06 |
 WHOLEY 85536007 4205748 Dead/Cancelled |
Robert Wholey & Co., Inc. 2012-02-07 |
 WHOLEY 79295809 not registered Live/Pending |
Naturo Pty Ltd 2020-08-26 |
 WHOLEY 75935619 2479494 Live/Registered |
ROBERT WHOLEY & CO., INC. 2000-03-03 |
 WHOLEY 75934864 2492163 Live/Registered |
ROBERT WHOLEY & CO., INC. 2000-03-03 |
 WHOLEY 75748846 2672523 Live/Registered |
Wholey, Mark H. 1999-07-13 |
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