Steerable Stent Positioner

Basic Information

• Brand Name: Steerable Stent Positioner
• Primary DI: 08714729904427
• Version / Model: M0061461900
• Company Name: BOSTON SCIENTIFIC CORPORATION
• Labeler DUNS: 021717889
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-11-03
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: be68b517-c8c8-40a8-baa5-52ce929d979f

Device Description

Steerable Stent Positioner

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: Yes
• 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
KOA	SURGICAL INSTRUMENTS, G-U, MANUAL (AND ACCESSORIES)	Gastroenterology, Urology	876.4730	1

GMDN Terms

Code	Name	Definition	Implantable	Status
13839	Urological catheter stylet, transurethral	A sterile, metal wire or flexible rod, typically with a plastic knob at the proximal end, intended to be inserted into the lumen of a urological catheter or cannula (not included) to increase stiffness sufficiently to facilitate manipulation/introduction into the urethra or ureter (via the urethra); it is not intended to assist introduction of a percutaneous catheter. It is available in various lengths, diameters, and degrees of rigidity. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08714729904427	GS1

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			1.6 mm Diameter
Device Size Text, specify			4.8 F Diameter