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
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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 provide a volume measurement for the appropriate selection of the implant; it is not designed for tissue expansion or to create the tissue pocket. 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 packaged with the sizer. This is a single-use device.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Regulatory Flags#

DUNS number
853166098
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
08058481670238WoundigenHUMAN BRAIN WAVE SRLFZW2026-09-24
08058481670269WoundigenHUMAN BRAIN WAVE SRLFZW2026-09-24
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