SpyGlass™ Discover M00542980

GUDID 00191506005238

Imager™ II IOC Catheter

BOSTON SCIENTIFIC CORPORATION

Laparoscopic cholangiography catheter

• Primary Device ID: 00191506005238
• NIH Device Record Key: 8e9b5b13-b28c-4d9e-b59a-b0013c51d286
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SpyGlass™ Discover
• Version Model Number: M00542980
• Catalog Number: M00542980
• Company DUNS: 021717889
• Company Name: BOSTON SCIENTIFIC CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Catheter Length: 65 Centimeter
• Catheter Gauge: 5 French
• Catheter Length: 65 Centimeter
• Catheter Gauge: 5 French
• Catheter Length: 65 Centimeter
• Catheter Gauge: 5 French
• Catheter Length: 65 Centimeter
• Catheter Gauge: 5 French
• Catheter Length: 65 Centimeter
• Catheter Gauge: 5 French
• Catheter Length: 65 Centimeter
• Catheter Gauge: 5 French
• Catheter Length: 65 Centimeter
• Catheter Gauge: 5 French
• Catheter Length: 65 Centimeter
• Catheter Gauge: 5 French
• Catheter Length: 65 Centimeter
• Catheter Gauge: 5 French
• Catheter Length: 65 Centimeter
• Catheter Gauge: 5 French
• Catheter Length: 65 Centimeter
• Catheter Gauge: 5 French
• Catheter Length: 65 Centimeter
• Catheter Gauge: 5 French
• Catheter Length: 65 Centimeter
• Catheter Gauge: 5 French
• Catheter Length: 65 Centimeter
• Catheter Gauge: 5 French
• Catheter Length: 65 Centimeter
• Catheter Gauge: 5 French
• Catheter Length: 65 Centimeter
• Catheter Gauge: 5 French
• Catheter Length: 65 Centimeter
• Catheter Gauge: 5 French
• Catheter Length: 65 Centimeter
• Catheter Gauge: 5 French
• Catheter Length: 65 Centimeter
• Catheter Gauge: 5 French
• Catheter Length: 65 Centimeter
• Catheter Gauge: 5 French
• Catheter Length: 65 Centimeter
• Catheter Gauge: 5 French
• Catheter Length: 65 Centimeter
• Catheter Gauge: 5 French
• Catheter Length: 65 Centimeter
• Catheter Gauge: 5 French
• Catheter Length: 65 Centimeter
• Catheter Gauge: 5 French
• Catheter Length: 65 Centimeter
• Catheter Gauge: 5 French
• Catheter Length: 65 Centimeter
• Catheter Gauge: 5 French
• Catheter Length: 65 Centimeter
• Catheter Gauge: 5 French
• Catheter Length: 65 Centimeter
• Catheter Gauge: 5 French
• Catheter Length: 65 Centimeter
• Catheter Gauge: 5 French
• Catheter Length: 65 Centimeter
• Catheter Gauge: 5 French
• Catheter Length: 65 Centimeter
• Catheter Gauge: 5 French
• Catheter Length: 65 Centimeter
• Catheter Gauge: 5 French
• Catheter Length: 65 Centimeter
• Catheter Gauge: 5 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00191506005221 [Primary]
GS1	00191506005238 [Package]; Contains: 00191506005221; Package: [5 Units]; In Commercial Distribution

FDA Product Code

• GBZ: CATHETER, CHOLANGIOGRAPHY

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-17
• Device Publish Date: 2021-06-09

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