Wholey™
GUDID 20763000919553
GW WWIJ35145 WHOLEY WIRE INT J 145CM
EV3, INC
Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual| Primary Device ID | 20763000919553 |
| NIH Device Record Key | 834264bf-064f-402f-8a12-b71159acf25e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Wholey™ |
| Version Model Number | WWIJ35145 |
| 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 | 145 Centimeter |
| Guidewire Diameter | 0.089 Centimeter |
| Guidewire Length | 145 Centimeter |
| Guidewire Diameter | 0.089 Centimeter |
| Guidewire Length | 145 Centimeter |
| Guidewire Diameter | 0.089 Centimeter |
| Guidewire Length | 145 Centimeter |
| Guidewire Diameter | 0.089 Centimeter |
| Guidewire Length | 145 Centimeter |
| Guidewire Diameter | 0.089 Centimeter |
| Guidewire Length | 145 Centimeter |
| Guidewire Diameter | 0.089 Centimeter |
| Guidewire Length | 145 Centimeter |
| Guidewire Diameter | 0.089 Centimeter |
| Guidewire Length | 145 Centimeter |
| Guidewire Diameter | 0.089 Centimeter |
| Guidewire Length | 145 Centimeter |
| Guidewire Diameter | 0.089 Centimeter |
| Guidewire Length | 145 Centimeter |
| Guidewire Diameter | 0.089 Centimeter |
| Guidewire Length | 145 Centimeter |
| Guidewire Diameter | 0.089 Centimeter |
| Guidewire Length | 145 Centimeter |
| Guidewire Diameter | 0.089 Centimeter |
| Guidewire Length | 145 Centimeter |
| Guidewire Diameter | 0.089 Centimeter |
| Guidewire Length | 145 Centimeter |
| Guidewire Diameter | 0.089 Centimeter |
| Guidewire Length | 145 Centimeter |
| Guidewire Diameter | 0.089 Centimeter |
| Guidewire Length | 145 Centimeter |
| Guidewire Diameter | 0.089 Centimeter |
| Guidewire Length | 145 Centimeter |
Operating and Storage Conditions
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000919559 [Primary] |
| GS1 | 20763000919553 [Package] Contains: 00763000919559 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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