Tissue Helix M00505460

GUDID 00191506060053

Tissue HeliX Pro

BOSTON SCIENTIFIC CORPORATION

Suturing unit, single-use

• Primary Device ID: 00191506060053
• NIH Device Record Key: 256a3bdc-180f-445a-b7d7-b44c6c9fb883
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tissue Helix
• Version Model Number: M00505460
• Catalog Number: M00505460
• 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	00191506060053 [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

• 00191506049379 - OverTube™: 2025-08-05 Endoscopic Access System
• 00191506060053 - Tissue Helix: 2025-08-05Tissue HeliX Pro
• 00191506060053 - Tissue Helix: 2025-08-05 Tissue HeliX Pro
• 00191506060060 - NXT Tissue HeliX Pro: 2025-08-05 Intragastric Balloon System
• 00191506060107 - OverStitch NXT ™: 2025-08-05 Intragastric Balloon System
• 08714729144182 - Optiflo: 2025-07-17 Hemostasis Catheter
• 08714729145264 - Optiflo: 2025-07-17 Hemostasis Catheter
• 08714729874805 - LithoVue: 2025-07-08 Single-Use Digital Flexible Ureteroscope
• 08714729874812 - LithoVue: 2025-07-08 Single-Use Digital Flexible Ureteroscope