Spatz3 Adjustable Balloon System® Adjustment/Extraction Kit

GUDID 00860005178827

The Spatz3 Adjustable Balloon System® Adjustment/Extraction Kit (A-SP3-015) contains 3 extension tubes with their 3-way stopcocks (P-SP-142), and 3 IFUs

SPATZ FGIA (ISRAEL) LTD

Appetite-suppression gastric balloon

• Primary Device ID: 00860005178827
• NIH Device Record Key: eece7818-31a1-4249-a7ac-5c7515171de3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spatz3 Adjustable Balloon System® Adjustment/Extraction Kit
• Version Model Number: A-SP3-015
• Company DUNS: 514763510
• Company Name: SPATZ FGIA (ISRAEL) LTD
• Device Count: 3
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860005178827 [Primary]
GS1	00860005178834 [Unit of Use]

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-28
• Device Publish Date: 2021-10-20

Devices Manufactured by SPATZ FGIA (ISRAEL) LTD

• 00860005178803 - Spatz3 Adjustable Balloon System insertion kit: 2021-10-28 The Spatz3 Adjustable Balloon System is indicated for temporary use for weight loss in adults with obesity Body Mass Index (BMI)
• 00860005178827 - Spatz3 Adjustable Balloon System® Adjustment/Extraction Kit: 2021-10-28The Spatz3 Adjustable Balloon System® Adjustment/Extraction Kit (A-SP3-015) contains 3 extension tubes with their 3-way stopcocks (P-SP-142), and 3 IFUs
• 00860005178827 - Spatz3 Adjustable Balloon System® Adjustment/Extraction Kit: 2021-10-28 The Spatz3 Adjustable Balloon System® Adjustment/Extraction Kit (A-SP3-015) contains 3 extension tubes with their 3-way stopcoc