OverStitch™ M00505410

GUDID 00191506060091

Intragastric Balloon System

BOSTON SCIENTIFIC CORPORATION

Suturing unit, single-use

• Primary Device ID: 00191506060091
• NIH Device Record Key: ee7f8bf6-05ae-4231-997a-4b5bfe7af828
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OverStitch™
• Version Model Number: M00505410
• Catalog Number: M00505410
• 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	00191506060091 [Primary]

FDA Product Code

• QTD: Endoscopic suturing device for altering gastric anatomy for weight loss

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: 2025-09-29
• Device Publish Date: 2025-09-19

On-Brand Devices [OverStitch™]

• 00191506060046: Suture Cinch
• 00191506060138: Polypropylene Suture
• 00191506060091: Intragastric Balloon System