Wholey™

Basic Information

• Brand Name: Wholey™
• Primary DI: 00763000185800
• Version / Model: WWES35001
• Company Name: Covidien LP
• Labeler DUNS: 968903703
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-10-25
• Public Version: 1
• Public Version Date: 2020-11-02
• Public Version Status: New
• Public Device Record Key: 307e7b13-d839-49f5-a7e3-d6709686d143

Device Description

GW WWES35001 WHOLEY WIRE V04

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DQX	Wire, guide, catheter	Cardiovascular	870.1330	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61281	Peripheral vascular guidewire extension	A long, thin, sterile wire designed to provide the necessary length to allow the exchange of a catheter, or other interventional device, while maintaining the intravascular position of the catheter guidewire during an interventional procedure in the peripheral vasculature. It is typically made of polymer-coated [e.g., polytetrafluoroethylene (PTFE)] stainless steel and is supplied with a connector (e.g., self-locking taper) to facilitate its joining to the proximal end of the in situ guidewire to create the extension (e.g., 150 mm). After the catheter exchange, the guidewire extension can be detached and the guidewire used as intended. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20763000185804	GS1	PK	3	In Commercial Distribution
Primary	00763000185800	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K120863	000

Device Sizes

Type	Value	Unit	Text
Guidewire Length	155.0	Centimeter
Guidewire Diameter	0.089	Centimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store the guidewire away from sunlight at room temperature in a dry place.