Alliance II

Basic Information

• Brand Name: Alliance II
• Primary DI: 08714729283881
• Version / Model: M00550620
• Company Name: BOSTON SCIENTIFIC CORPORATION
• Labeler DUNS: 021717889
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 5
• Public Version Date: 2020-09-30
• Public Version Status: Update
• Public Device Record Key: 4b60472d-6207-44a8-86b9-8db0bdbf122a

Device Description

Integrated Inflation/Litho Device

Device Characteristics

• Single Use: No
• 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: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KNT	TUBES, GASTROINTESTINAL (AND ACCESSORIES)	Gastroenterology, Urology	876.5980	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64842	Biliary stone fragmenter/catheter-balloon inflator handle	A manual device intended to be attached to the proximal end of a manual biliary stone fragmenter and a catheter-balloon inflator (neither included) to operate the fragmenter and inflator plunger during an endoscopic procedure to fragment/retrieve stones or inflate the catheter balloon. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08714729283881	GS1