FDA.reportPublic FDA data

Spatz3 Adjustable Balloon System® Adjustment/Extraction Kit

Primary DI
00860005178827
Brand
Spatz3 Adjustable Balloon System® Adjustment/Extraction Kit
Company
SPATZ FGIA (ISRAEL) LTD
Model
A-SP3-015
Device description
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
Published
2021-10-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860005178827PrimaryGS10
00860005178834Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860005178827008600051788278600051788270860005178827
00860005178834008600051788348600051788340860005178834

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
514763510
Device count
3
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
00860005178803Spatz3 Adjustable Balloon System insertion kit A-SP3US-03K2021-10-20