X-Tack™ M00505510

GUDID 00191506049164

Endoscopic HeliX Tacking System (Colonic)

BOSTON SCIENTIFIC CORPORATION

Gastrointestinal suture anchor

• Primary Device ID: 00191506049164
• NIH Device Record Key: 38eb11ea-8a10-4f98-bc55-3aaa0fd65262
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: X-Tack™
• Version Model Number: M00505510
• Catalog Number: M00505510
• Company DUNS: 021717889
• Company Name: BOSTON SCIENTIFIC CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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	00191506049164 [Primary]

FDA Product Code

• PKL: Hemostatic metal clip for the GI tract

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: 2025-02-25
• Device Publish Date: 2025-02-17

On-Brand Devices [X-Tack™]

• 00191506049164: Endoscopic HeliX Tacking System (Colonic)
• 00191506049157: Endoscopic HeliX Tacking System (Gastric)