Spatz3 Adjustable Balloon System insertion kit

FDA UDI

Class III (US FDA UDI)

by Spatz Fgia (israel) Ltd

Identity

Trade Name: Spatz3 Adjustable Balloon System insertion kit FDA UDI
Generic Name: Appetite-suppression gastric balloon FDA UDI
Device Name: 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. FDA UDI
Model / Reference: A-SP3US-03K FDA UDI
Description: 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. FDA UDI

Identifiers

Primary DI / UDI-DI: 00860005178803 FDA UDI
FDA Product Code: LTI FDA UDI
GMDN Term: Appetite-suppression gastric balloon FDA UDI

Classification

Device Class: Class III FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Appetite-suppression gastric balloon

Spatz3 Adjustable Balloon System insertion kit by Spatz Fgia (israel) Ltd — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Appetite-suppression gastric balloon.

ORBERA Intragastric Balloon System — Apollo Endosurgery · Class III
Spatz3 Adjustable Balloon System® Adjustment/Extraction Kit — SPATZ FGIA (ISRAEL) LTD

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class III	Pending data

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Manufacturer

Manufacturer: Spatz Fgia (israel) Ltd

Sources (1)

FDA UDI 3656146d-1839-43f3-be27-92103f09c7ed 34 fields · synced May 29, 2026