FDA.reportPublic FDA data

Remeex System -Readjustment kit Long

Primary DI
08436568350882
Brand
Remeex System -Readjustment kit Long
Company
DESARROLLO E INVESTIGACION MEDICA ARAGONESA SL
Model
AR-01L
Published
2020-10-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OTMMesh, Surgical, For Stress Urinary Incontinence, Male

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OTMMesh, Surgical, For Stress Urinary Incontinence, MaleGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08436568350882PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08436568350882084365683508828436568350882

GMDN Terms#

Term, Definition table
TermDefinition
Obstetrical/gynaecological surgical procedure kit, non-medicated, single-useA collection of various sterile surgical instruments, dressings/drapes, and materials intended to be used during obstetrical/gynaecological surgery. The kit may be referred to as a procedure pack and is typically comprised of devices that individually are not dedicated to a specific type of obstetrical/gynaecological surgical procedure, but are often supplied together to perform a specific type of obstetrical/gynaecological procedure; it does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
513271056
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08436568350899Male Remeex System - Thread PasserAR-072020-10-19
08437007606263Remeex System - Thread PasserAR-032020-10-19
08436568350141AnchorsureA-SURE022020-10-19
08437007606904AnchorsureA-SURE2020-10-19
08437007606027Remeex System (for Female Urinary Incontinence)SREM-012020-10-19
08437007606034Male Remeex System MRS2020-10-19
08437007606058Needleless SlingNL-01 2020-10-19
08437007606065KIM (Knotless Incontinence Mesh)KIM01/OID52020-10-19
08437007606683KIM (Knotless Incontinence Mesh)KIM-012020-10-19
08437007606072Remeex System -Readjustment kit AR-012020-10-19
08437007606232Male Remeex System - Readjustment kit AR-01P2020-10-19
08437007606836Remeex System - Passer Handle AR-052020-10-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00191506003999AdVance™ XPBOSTON SCIENTIFIC CORPORATIONOTM2022-03-21
08436568350899Male Remeex System - Thread PasserDESARROLLO E INVESTIGACION MEDICA ARAGONESA SLOTM2020-10-19
08437007606034Male Remeex System DESARROLLO E INVESTIGACION MEDICA ARAGONESA SLOTM2020-10-19
08437007606232Male Remeex System - Readjustment kit DESARROLLO E INVESTIGACION MEDICA ARAGONESA SLOTM2020-10-19
08437007606836Remeex System - Passer Handle DESARROLLO E INVESTIGACION MEDICA ARAGONESA SLOTM2020-10-19
00878953005560AdVance™ XPBOSTON SCIENTIFIC CORPORATIONOTM2019-01-04
03760151650239I-STOP TOMSCL MEDICALOTM2017-05-19
00878953005300AdVance AMERICAN MEDICAL SYSTEMS, INC.OTM2016-07-22
00878953005881AdVance AMERICAN MEDICAL SYSTEMS, INC.OTM2016-07-22
00878953005898AdVance AMERICAN MEDICAL SYSTEMS, INC.OTM2016-07-22
05708932499149VirtueColoplast A/SOTM2015-10-22