BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

HI-TORQUE FLEX-T

DI: 08717648124136 · Model: 1012067-04 · ABBOTT VASCULAR INC.

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Product Codes

1

GMDN Terms

1

Identifiers

2

Pkg Device Count

1

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Basic Information

Brand Name: HI-TORQUE FLEX-T
Primary DI: 08717648124136
Version / Model: 1012067-04
Catalog Number: 1012067-04
Company Name: ABBOTT VASCULAR INC.
Labeler DUNS: 964569052
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2016-03-01
Public Version: 3
Public Version Date: 2021-12-22
Public Version Status: Update
Public Device Record Key: 0211bc1c-10d2-4bc6-84ff-46560e7f9c95

Device Description

HI-TORQUE FLEX-T Guide Wire System with MICROGLIDE Coating .018 295 cm

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
58115	Peripheral vascular guidewire, manual	A long, thin wire intended to be percutaneously placed into the peripheral vasculature (not heart or central nervous system) to function as a guide for the introduction of devices (e.g., catheters). It is made of metal (e.g., stainless steel, Nitinol), with or without coating, and is available in a variety of distal tip designs. It is intended to be used for percutaneous angiography, angioplasty, rotational atherectomy and thrombectomy, drainage, and other diagnostic and interventional procedures. It may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	28717648124130	GS1	Case	5	In Commercial Distribution
Primary	08717648124136	GS1

Customer Contacts

Phone: +1(800)227-9902
Email: [email protected]

Storage Conditions

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