FDA.reportPublic FDA data

Spatz3 Adjustable Balloon System insertion kit

Primary DI
00860005178803
Brand
Spatz3 Adjustable Balloon System insertion kit
Company
SPATZ FGIA (ISRAEL) LTD
Model
A-SP3US-03K
Device 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.
Published
2021-10-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
LTIImplant, Intragastric For Morbid Obesity

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LTIImplant, Intragastric For Morbid ObesityUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860005178803PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860005178803008600051788038600051788030860005178803

GMDN Terms#

Term, Definition table
TermDefinition
Appetite-suppression gastric balloonAn expandable device intended to be inflated in the stomach to create a feeling of satiety and reduce the desire for food. The device is inserted via a catheter and may be retained in the stomach where it degrades over a period. Disposable devices dedicated to introduction may be included.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature60 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
514763510
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860005178827Spatz3 Adjustable Balloon System® Adjustment/Extraction KitA-SP3-0152021-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810010540119Allurion™ Gastric Balloon SystemAllurion Technologies, Inc.LTI2026-04-07
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03665039005630Extraction Kit PRINCE MEDICALLTI2024-01-30
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