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

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
07445161009494Motiva® Inflatable BalloonMIB-0080MIB-00802025-06-06
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
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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

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