FDA.reportPublic FDA data

Motiva® Inflatable Balloon

Primary DI
07445161009494
Brand
Motiva® Inflatable Balloon
Company
Establishment Labs S.A.
Model
MIB-0080
Catalog number
MIB-0080
Device description
Motiva® Inflatable Balloon - 8 cm base
Published
2025-06-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FZWExpander, Surgical, Skin Graft

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZWExpander, Surgical, Skin GraftGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07445161009494PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07445161009494074451610094947445161009494

GMDN Terms#

Term, Definition table
TermDefinition
Invasive breast implant sizer, inflatableA manual inflatable device intended to be inserted intraoperatively into a tissue pocket surgically-created for the acceptance of a breast augmentation implant, to ascertain that sufficient space has been created for the placement of the implant. It is a balloon-like device connected to a manually-powered air pump used to expand the device; devices associated with the sizer introduction may be included. This is a single-use device.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Regulatory Flags#

DUNS number
853166098
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07445161009579Motiva® Inflatable BalloonMIB-0090MIB-00902025-06-06
07445161009586Motiva® Inflatable BalloonMIB-0100MIB-01002025-06-06
07445161027290Motiva® Channel SeparatorMCS-20USMCS-20US2025-06-06
07445161001702Motiva® SmoothSilk® Round Breast Implant RSM-245+RSM-245+2024-10-04
07445161001719Motiva® SmoothSilk® Round Breast Implant RSM-260+RSM-260+2024-10-04
07445161001726Motiva® SmoothSilk® Round Breast Implant RSM-275+RSM-275+2024-10-04
07445161001733Motiva® SmoothSilk® Round Breast Implant RSM-290+RSM-290+2024-10-04
07445161001740Motiva® SmoothSilk® Round Breast Implant RSM-310+RSM-310+2024-10-04
07445161001757Motiva® SmoothSilk® Round Breast Implant RSM-360+RSM-360+2024-10-04
07445161001764Motiva® SmoothSilk® Round Breast Implant RSM-400+RSM-400+2024-10-04
07445161001849Motiva® SmoothSilk® Round Breast Implant RSD-205+RSD-205+2024-10-04
07445161001856Motiva® SmoothSilk® Round Breast Implant RSD-215+RSD-215+2024-10-04
07445161001863Motiva® SmoothSilk® Round Breast Implant RSD-230+RSD-230+2024-10-04
07445161001870Motiva® SmoothSilk® Round Breast Implant RSD-245+RSD-245+2024-10-04
07445161001887Motiva® SmoothSilk® Round Breast Implant RSD-265+RSD-265+2024-10-04
07445161001894Motiva® SmoothSilk® Round Breast Implant RSD-285+RSD-285+2024-10-04
07445161001900Motiva® SmoothSilk® Round Breast Implant RSD-300+RSD-300+2024-10-04
07445161001917Motiva® SmoothSilk® Round Breast Implant RSD-320+RSD-320+2024-10-04
07445161001924Motiva® SmoothSilk® Round Breast Implant RSD-340+RSD-340+2024-10-04
07445161001931Motiva® SmoothSilk® Round Breast Implant RSD-360+RSD-360+2024-10-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07445161009579Motiva® Inflatable BalloonEstablishment Labs S.A.FZW2025-06-06
07445161009586Motiva® Inflatable BalloonEstablishment Labs S.A.FZW2025-06-06
04049197024686RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFZW2024-10-02
04049197024693RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFZW2024-10-02
04049197024709RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFZW2024-10-02
00810006780123Mesh ExEXSURCO MEDICAL, INC.FZW2024-03-20
00810006780130Mesh Ex EXSURCO MEDICAL, INC.FZW2024-03-20
00810006780147Mesh ExEXSURCO MEDICAL, INC.FZW2024-03-20
00810006780154Mesh ExEXSURCO MEDICAL, INC.FZW2024-03-20
00810006780185Mesh ExEXSURCO MEDICAL, INC.FZW2024-03-20
00810006780192Mesh ExEXSURCO MEDICAL, INC.FZW2024-03-20
00810006780215Mesh ExEXSURCO MEDICAL, INC.FZW2024-03-20
06975808860603MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.FZW2024-01-22
07540162040429Imperial Stackable StepstoolImperial Surgical LtdFZW2023-07-28
06975808860214MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.FZW2023-03-16
06975808860238MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.FZW2023-03-16
06975808860313MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.FZW2023-03-16
05033955099015Swann Morton Ltd.SWANN-MORTON LIMITEDFZW2022-09-27
05033955099022Swann Morton Ltd.SWANN-MORTON LIMITEDFZW2022-09-27
05033955099039Swann Morton Ltd.SWANN-MORTON LIMITEDFZW2022-09-27
05033955099046Swann Morton Ltd.SWANN-MORTON LIMITEDFZW2022-09-27
05033955099053Swann Morton Ltd.SWANN-MORTON LIMITEDFZW2022-09-27
05033955099060Swann Morton Ltd.SWANN-MORTON LIMITEDFZW2022-09-27
05033955099091Swann Morton Ltd.SWANN-MORTON LIMITEDFZW2022-09-27
05033955099114Swann Morton Ltd.SWANN-MORTON LIMITEDFZW2022-09-27
05033955099121Swann Morton Ltd.SWANN-MORTON LIMITEDFZW2022-09-27
00855638007149Brennen Skin Graft MesherSTELLEN MEDICAL, LLCFZW2022-08-10
00855638007156Brennen Skin Graft MesherSTELLEN MEDICAL, LLCFZW2022-08-10
00855638007163Brennen Skin Graft MesherSTELLEN MEDICAL, LLCFZW2022-08-10
00855638007170Brennen Skin Graft MesherSTELLEN MEDICAL, LLCFZW2022-08-10