Wholey WWFS35175
GUDID 00821684049389
Guidewire System;Floppy Tip, Extension Compatible
Covidien LP
Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual| Primary Device ID | 00821684049389 |
| NIH Device Record Key | cecbd4b4-83af-4beb-8325-150284142385 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Wholey |
| Version Model Number | WWFS35175 |
| Catalog Number | WWFS35175 |
| Company DUNS | 968903703 |
| Company Name | Covidien LP |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does n |
| 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 | true |
| 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(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com |
Device Dimensions
| Length | 175 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 175 Centimeter |
| Outer Diameter | 0.035 Inch |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry; Avoid direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry; Avoid direct sunlight |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00821684049389 [Package] Contains: 00821684058619 Package: PK [3 Units] In Commercial Distribution |
| GS1 | 00821684058619 [Primary] |
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 | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-10-16 |
On-Brand Devices [Wholey]
| 00821684049389 | Guidewire System;Floppy Tip, Extension Compatible |
| 00821684049372 | Guidewire System;Floppy Tip, Extension Compatible |
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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