SpyScope DS

Basic Information

• Brand Name: SpyScope DS
• Primary DI: 08714729863236
• Version / Model: M00546600
• 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: 3
• Public Version Date: 2019-02-08
• Public Version Status: Update
• Public Device Record Key: 7f5a7e01-8377-4f0f-9023-4ef8d84fcb5c

Device Description

Access and Delivery 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: 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
FBN	Choledochoscope and accessories, flexible/rigid	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36626	Flexible video choledochoscope	An endoscope with a flexible inserted portion intended for the visual examination and treatment of the choledoc, better known as the common bile duct (CBD). It is inserted into the body through an artificial orifice created by an incision in the abdomen (laparoscopic technique) or introduced via a flexible duodenoscope during the procedure called choledochoscopy. Anatomical images are transmitted to the user by a video system with a charge-coupled device (CCD) chip at the distal end and the images showing on a monitor. This device is commonly used to examine structures of the CBD and for the removal of stones. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08714729863236	GS1