FDA.reportPublic FDA data

Male Remeex System

Primary DI
08437007606034
Brand
Male Remeex System
Company
DESARROLLO E INVESTIGACION MEDICA ARAGONESA SL
Model
MRS
Published
2020-10-19
Public version status
Update
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
08437007606034PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08437007606034084370076060348437007606034

GMDN Terms#

Term, Definition table
TermDefinition
Urethral sphincter prosthesis systemA sterile implantable assembly of devices indicated for incontinence and intended to support or replace a natural urethral sphincter. It is a hydraulically-operated system typically consisting of a single or double cuff to surround the urethra, a reservoir for the hydraulic liquid, e.g., saline with/without radiopacifier, and a manually driven pump. It is made of a non-bioabsorbable polymeric material.

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
08437007606058Needleless SlingNL-01 2020-10-19
08437007606065KIM (Knotless Incontinence Mesh)KIM01/OID52020-10-19
08437007606683KIM (Knotless Incontinence Mesh)KIM-012020-10-19
08436568350882Remeex System -Readjustment kit LongAR-01L2020-10-19
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
08436568350882Remeex System -Readjustment kit LongDESARROLLO E INVESTIGACION MEDICA ARAGONESA SLOTM2020-10-19
08436568350899Male Remeex System - Thread PasserDESARROLLO 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