Spatz3 Adjustable Balloon System insertion kit

GUDID 00860005178803

The Spatz3 Adjustable Balloon System is indicated for temporary use for weight loss in adults with obesity Body Mass Index (BMI) of 35.0-40.0 kg/m2 or a BMI of 30.0 to 34.9 kg/m2 with one or more major obesity-related comorbid conditions who have failed to achieve and maintain weight-loss with a supervised weight control program. The Spatz3 Adjustable Balloon System is to be used in conjunction with a long-term supervised diet and behavior modification program designed to increase the possibility of long-term weight-loss maintenance. The maximum placement period for Spatz3 Adjustable Balloon System is 8 months.

SPATZ FGIA (ISRAEL) LTD

Appetite-suppression gastric balloon

• Primary Device ID: 00860005178803
• NIH Device Record Key: 3656146d-1839-43f3-be27-92103f09c7ed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spatz3 Adjustable Balloon System insertion kit
• Version Model Number: A-SP3US-03K
• Company DUNS: 514763510
• Company Name: SPATZ FGIA (ISRAEL) LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860005178803 [Primary]

FDA Product Code

• LTI: Implant, Intragastric For Morbid Obesity

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: 2021-10-28The Spatz3 Adjustable Balloon System is indicated for temporary use for weight loss in adults with obesity Body Mass Index (BMI) of 35.0-40.0 kg/m2 or a BMI of 30.0 to 34.9 kg/m2 with one or more major obesity-related comorbid conditions who have failed to achieve and maintain weight-loss with a supervised weight control program. The Spatz3 Adjustable Balloon System is to be used in conjunction with a long-term supervised diet and behavior modification program designed to increase the possibility of long-term weight-loss maintenance. The maximum placement period for Spatz3 Adjustable Balloon System is 8 months.
• 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: 2021-10-28 The Spatz3 Adjustable Balloon System® Adjustment/Extraction Kit (A-SP3-015) contains 3 extension tubes with their 3-way stopcoc