FDA.reportPublic FDA data

Motiva® Channel Separator

Primary DI
07445161027290
Brand
Motiva® Channel Separator
Company
Establishment Labs S.A.
Model
MCS-20US
Catalog number
MCS-20US
Device description
Motiva® Channel Separator
Published
2025-06-06
Public version status
Update
Distribution status
Not 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
GDIDissector, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDIDissector, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07445161027290PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07445161027290074451610272907445161027290

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery dissectorA hand-held surgical instrument, usually spoon-shaped or rounded at the working end, used to separate a soft tissue or body structure from another. It is used in general or plastic surgery and is usually designed with a handle which continues into a shaft that terminates at the distal end with a tip. The tip may be pointed or flat, sharp or blunt, and angled or straight from the shaft. It is made of high-grade stainless steel, comes in various shapes and sizes. This is a reusable device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

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
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
07445161001931Motiva® SmoothSilk® Round Breast Implant RSD-360+RSD-360+2024-10-04

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07898789390060FRONTO MARTINS 2 ENDOFOREHEAD DISSECTORTOYO COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTOS CIRURGICOS LTDAGDI2026-03-25
07898789390015TREPSAT FACELIFT DISSECTORTOYO COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTOS CIRURGICOS LTDAGDI2026-03-23
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