Model: ABFBF-011V
Catalog: IN32180J1
DI: 00816349015755
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-12
Current Version: 2026-05-20
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
0f016824-2e8f-46a2-8495-45e1fe7849ee
Distribution Status:
In Commercial Distribution
DUNS Number:
031108704
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00816349015755
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 58115
Name: Peripheral vascular guidewire, manual
Definition:
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.
FDA Product Codes
DQX
Wire, Guide, Catheter
Device Sizes
Item #1 - Size - @attributes - Unit:
Centimeter
Item #1 - Size - @attributes - Value:
180
Item #1 - Size Type:
Guidewire Length
Item #2 - Size - @attributes - Unit:
Inch
Item #2 - Size - @attributes - Value:
0.032
Item #2 - Size Type:
Guidewire Diameter