SpyGlass™ Discover

GUDID 08714729998754

Digital Controller

BOSTON SCIENTIFIC CORPORATION

Endoscopic video image processing/light source system Endoscopic video image processing/light source system Endoscopic video image processing/light source system Endoscopic video image processing/light source system Endoscopic video image processing/light source system Endoscopic video image processing/light source system Endoscopic video image processing/light source system Endoscopic video image processing/light source system Endoscopic video image processing/light source system Endoscopic video image processing/light source system Endoscopic video image processing/light source system Endoscopic video image processing/light source system Endoscopic video image processing/light source system Endoscopic video image processing/light source system Endoscopic video image processing/light source system Endoscopic video image processing/light source system

• Primary Device ID: 08714729998754
• NIH Device Record Key: 48e510e4-5d32-43b8-8308-a7c43ad79fcd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SpyGlass™ Discover
• Version Model Number: M0054295R0
• Company DUNS: 021717889
• Company Name: BOSTON SCIENTIFIC CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08714729998754 [Primary]

FDA Product Code

• NTN: Led light source

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-06-12
• Device Publish Date: 2020-06-04

On-Brand Devices [SpyGlass™ Discover]

• 08714729998754: Digital Controller
• 08714729998723: Digital Controller
• 08714729994183: Digital Catheter
• 00191506004774: Jagwire™ Guidewire
• 00191506004255: SpyGlass™ Discover Retrieval Basket
• 00191506005238: Imager™ II IOC Catheter
• 00191506013516: Balloon Dilation Catheter
• 00191506013509: Balloon Dilation Catheter
• 00191506013493: Balloon Dilation Catheter