SpyGlass™ Discover

Basic Information

• Brand Name: SpyGlass™ Discover
• Primary DI: 00191506005221
• Version / Model: M00542980
• Catalog Number: M00542980
• Company Name: BOSTON SCIENTIFIC CORPORATION
• Labeler DUNS: 021717889
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-06-09
• Public Version: 1
• Public Version Date: 2021-06-17
• Public Version Status: New
• Public Device Record Key: 8e9b5b13-b28c-4d9e-b59a-b0013c51d286

Device Description

Imager™ II IOC Catheter

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
GBZ	CATHETER, CHOLANGIOGRAPHY	General, Plastic Surgery	878.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64505	Laparoscopic cholangiography catheter	A flexible, single-lumen tube intended to be introduced into the biliary system (Hartmann’s pouch and/or cystic duct), via a surgically-created incision, to allow injection of contrast media during laparoscopic cholangiography; it does not include a needle. It may include disposable devices dedicated to catheter introduction/function (e.g., adaptor, guide sleeve). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00191506005238	GS1		5	In Commercial Distribution
Primary	00191506005221	GS1

Device Sizes

Type	Value	Unit	Text
Catheter Length	65	Centimeter
Catheter Gauge	5	French