DOC

Basic Information

• Brand Name: DOC
• Primary DI: 08717648013317
• Version / Model: 22260
• Catalog Number: 22260
• Company Name: ABBOTT VASCULAR INC.
• Labeler DUNS: 964569052
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-02-05
• Public Version: 6
• Public Version Date: 2024-02-07
• Public Version Status: Update
• Public Device Record Key: 75445ccd-e974-4d9f-824a-9c07e7f19514

Device Description

DOC Guide Wire Extension

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: Yes
• 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
48137	Coronary artery guidewire extension	A long, thin, sterile wire designed to provide the necessary length to allow the exchange of one coronary artery dilatation catheter for another, while maintaining the position of the cardiac catheter guidewire in the coronary artery, during angiography or percutaneous transluminal coronary angioplasty (PTCA). It is typically made of polymer-coated [e.g., polytetrafluoroethylene (PTFE)] stainless steel and supplied with a guidewire extension insertion device to facilitate its joining to the proximal end of the in situ guidewire. 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
Primary	08717648013317	GS1
Package	28717648013311	GS1	Case	5	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K931171	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Stored in a dry, dark, cool place