FDA.reportPublic FDA data

Flora™ Tissue Expander SMOOTHSILK®

Primary DI
07445161020840
Brand
Flora™ Tissue Expander SMOOTHSILK®
Company
Establishment Labs S.A.
Model
L-11-260
Catalog number
L-11-260
Device description
Flora™ Tissue Expander SMOOTHSILK®Motiva® Flora® SmoothSilk Tissue Expander - Corsé Low Height 260cc
Published
2023-11-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LCJTissue Expander And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LCJTissue Expander And AccessoriesUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211676000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211676000Motiva Flora SmoothSilk Tissue ExpanderMotiva USA, LLC2023-10-13LCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07445161020840PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07445161020840074451610208407445161020840

GMDN Terms#

Term, Definition table
TermDefinition
Skin-port tissue expanderAn expandable device intended for implantation to temporarily enlarge tissue, typically the dimensions of a skin flap where there is insufficient tissue coverage to accommodate the volume of an implantable device (e.g., a breast implant), or for the revision of a scar or cutaneous defect. The device typically consists of an expansion envelope (e.g., silicone elastomer) with fill tube and an inflation valve, and is expanded percutaneously with air or fluid through a subcutaneous port accessed by a healthcare professional. This is a single-use device.

Sterilization Methods#

Method table
Method
Dry Heat Sterilization

Regulatory Flags#

DUNS number
853166098
Device count
1
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
07445161009494Motiva® Inflatable BalloonMIB-0080MIB-00802025-06-06
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00650551006596INTEGRAPMT CORPORATIONLCJ2026-05-27
00650551006022INTEGRAPMT CORPORATIONLCJ2026-05-18
00650551006039INTEGRAPMT CORPORATIONLCJ2026-05-18
00650551006046INTEGRAPMT CORPORATIONLCJ2026-05-18
00650551006060INTEGRAPMT CORPORATIONLCJ2026-05-18
00650551006077INTEGRAPMT CORPORATIONLCJ2026-05-18
00650551006084INTEGRAPMT CORPORATIONLCJ2026-05-18
00650551006176INTEGRAPMT CORPORATIONLCJ2026-05-18
00650551006237INTEGRAPMT CORPORATIONLCJ2026-05-18
00650551006503INTEGRAPMT CORPORATIONLCJ2026-05-18
00650551006510INTEGRAPMT CORPORATIONLCJ2026-05-18
00840124521889PolyLock MidfootFUSION ORTHOPEDICS, LLCLCJ2025-10-02
00650551005391INTEGRA®PMT CORPORATIONLCJ2025-03-26
10081317032332MENTOR CPX4 PLUS Enhance, Smooth, Tall HeightMENTOR TEXAS L.P.LCJ2025-03-26
00650551002154INTEGRA®PMT CORPORATIONLCJ2025-03-19
00650551002161INTEGRA®PMT CORPORATIONLCJ2025-03-19
00650551002772INTEGRA®PMT CORPORATIONLCJ2025-03-19
00650551002833INTEGRA®PMT CORPORATIONLCJ2025-03-19
00650551002963INTEGRA®PMT CORPORATIONLCJ2025-03-19
00650551003083INTEGRA®PMT CORPORATIONLCJ2025-03-19
00650551003090INTEGRA®PMT CORPORATIONLCJ2025-03-19
00650551003168INTEGRA®PMT CORPORATIONLCJ2025-03-19
00650551003175INTEGRA®PMT CORPORATIONLCJ2025-03-19
00650551003182INTEGRA®PMT CORPORATIONLCJ2025-03-19
00650551003205INTEGRA®PMT CORPORATIONLCJ2025-03-19
00650551003212INTEGRA®PMT CORPORATIONLCJ2025-03-19
00650551003243INTEGRA®PMT CORPORATIONLCJ2025-03-19
00650551003311INTEGRA®PMT CORPORATIONLCJ2025-03-19
00650551003328INTEGRA®PMT CORPORATIONLCJ2025-03-19
00650551003335INTEGRA®PMT CORPORATIONLCJ2025-03-19