Axios™

Basic Information

• Brand Name: Axios™
• Primary DI: 08714729904632
• Version / Model: M00553750
• Company Name: BOSTON SCIENTIFIC CORPORATION
• Labeler DUNS: 021717889
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-13
• Public Version: 5
• Public Version Date: 2023-02-02
• Public Version Status: Update
• Public Device Record Key: 72b46bb8-970b-4d6b-a499-0e66b73375cf

Device Description

Stent and Delivery System

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: MR Conditional
• 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
PCU	pancreatic stent, covered, metallic, removable	Gastroenterology, Urology	876.5015	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62611	Implantable transenteric drainage tube	A non-bioabsorbable tube intended to be endoscopically implanted transmurally between the gastrointestinal (GI) tract and a pancreatic pseudocyst or the biliary tract for drainage. It is a flanged stent-like structure made of metal which is covered/lined with a synthetic polymer material (e.g., silicone). It is typically expanded in situ (e.g., with a balloon catheter or self-expands) and disposable devices to assist implantation, with or without electrosurgical functionality, may be included with the device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08714729904632	GS1

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			15 mm Stent Diameter
Device Size Text, specify			10 mm Effective Length