NXT Tissue HeliX Pro M00505490

GUDID 00191506060060

Intragastric Balloon System

BOSTON SCIENTIFIC CORPORATION

Suturing unit, single-use

• Primary Device ID: 00191506060060
• NIH Device Record Key: 816e35c4-b0ab-4d1a-a604-261c0b582db3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NXT Tissue HeliX Pro
• Version Model Number: M00505490
• Catalog Number: M00505490
• 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: 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 Identifiers

Device Issuing Agency	Device ID
GS1	00191506060060 [Primary]

FDA Product Code

• OCW: Endoscopic tissue approximation device

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: 2025-08-05
• Device Publish Date: 2025-07-28

Devices Manufactured by BOSTON SCIENTIFIC CORPORATION

• 08714729878018 - Viking™: 2025-09-08 Fixed Curve Diagnostic Catheter
• 08714729878025 - Viking™: 2025-09-08 Fixed Curve Diagnostic Catheter
• 08714729878049 - Viking™: 2025-09-08 Fixed Curve Diagnostic Catheter
• 08714729878056 - Viking™: 2025-09-08 Fixed Curve Diagnostic Catheter
• 08714729878063 - Viking™: 2025-09-08 Fixed Curve Diagnostic Catheter
• 08714729878070 - Viking™: 2025-09-08 Fixed Curve Diagnostic Catheter
• 08714729878087 - Viking™: 2025-09-08 Fixed Curve Diagnostic Catheter
• 08714729878094 - Viking™: 2025-09-08 Fixed Curve Diagnostic Catheter