Male Remeex System - Thread Passer

Primary DI
08436568350899
Brand
Male Remeex System - Thread Passer
Company
DESARROLLO E INVESTIGACION MEDICA ARAGONESA SL
Model
AR-07
Published
2020-10-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
08436568350899PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08436568350899084365683508998436568350899

GMDN Terms#

Term, Definition table
TermDefinition
Transvaginal needle, surgicalA hand-held manual surgical instrument with a sharp pyramidal or conical point designed to create a puncture in the vaginal wall for the surgical positioning of a sling typically used in the treatment of stress urinary incontinence (SUI) associated with bladder prolapse. The distal working end is typically made of a high-grade stainless steel curved rod with a pointed tip and an eye or notch to help position the sling. The proximal end can have a handle made of metal or durable plastic. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
513271056
Device count
1
Lot or batch
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
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
00191506003999AdVanceā„¢ XPBOSTON SCIENTIFIC CORPORATIONOTM2022-03-21
08436568350882Remeex System -Readjustment kit LongDESARROLLO 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
00878953005560AdVanceā„¢ 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