SPATZ FGIA (ISRAEL) LTD

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Implant, Intragastric For Morbid Obesity (LTI) (1)

Premarket Exempt

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Spatz3 Adjustable Balloon System insertion kit - 00860005178803 Catalog Number :

Device Description : The Spatz3 Adjustable Balloon System is indicated for temporary use for weight l 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.

Device Class : 3

Duns Number: 514763510

Premarket Exempt : No

Product Code : LTI

Prescription Use : Yes

Device Count : 1

Spatz3 Adjustable Balloon System® Adjustment/Extraction Kit - 00860005178827 Catalog Number :

Device Description : The Spatz3 Adjustable Balloon System® Adjustment/Extraction Kit (A-SP3-015) cont 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

Device Class :

Duns Number: 514763510

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 3

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