FDA.reportPublic FDA data

Remeex System - Passer Handle

Primary DI
08437007606836
Brand
Remeex System - Passer Handle
Company
DESARROLLO E INVESTIGACION MEDICA ARAGONESA SL
Model
AR-05
Published
2020-10-19
Public version status
New
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
OTNMesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OTMMesh, Surgical, For Stress Urinary Incontinence, MaleGeneral, Plastic Surgery2
OTNMesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or TransobturatorGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08437007606836PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08437007606836084370076068368437007606836

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument handle, non-torque-limitingA hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. 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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00890594000124Desara Blue TVez 3.0Caldera Medical, Inc.OTN2022-08-03
00890594000131Desara TVez 2.7Caldera Medical, Inc.OTN2022-08-03
00890594000155Desara TVez 3.0Caldera Medical, Inc.OTN2022-08-03
00890594000193Desara Blue TVez 2.7Caldera Medical, Inc.OTN2022-08-03
00191506003999AdVance™ XPBOSTON SCIENTIFIC CORPORATIONOTM2022-03-21
00890594000087Desara Blue TVez 3.0Caldera Medical, Inc.OTN2021-11-15
00890594000094Desara Blue TVez 2.7Caldera Medical, Inc.OTN2021-11-15
00890594000100Desara TVez 2.7Caldera Medical, Inc.OTN2021-11-15
00890594000117Desara TVez 3.0Caldera Medical, Inc.OTN2021-11-15
00191506007652Advantage Ultra SystemBOSTON SCIENTIFIC CORPORATIONOTN2021-10-06
00191506007669Advantage Fit Ultra SystemBOSTON SCIENTIFIC CORPORATIONOTN2021-10-06
00191506007676Lynx Ultra SystemBOSTON SCIENTIFIC CORPORATIONOTN2021-10-06
00860003619810Athena Surgical RMUS SystemAthena Surgical LLCOTN2021-07-30
00860003619803Athena Surgical RMUS SystemAthena Surgical LLCOTN2021-07-30
20860003619814Athena Surgical RMUS SystemAthena Surgical LLCOTN2021-07-30
00860003619827Athena Surgical RMUS SystemAthena Surgical LLCOTN2021-07-30
08436568350882Remeex System -Readjustment kit LongDESARROLLO E INVESTIGACION MEDICA ARAGONESA SLOTM2020-10-19
08436568350899Male Remeex System - Thread PasserDESARROLLO E INVESTIGACION MEDICA ARAGONESA SLOTM2020-10-19
08437007606027Remeex System (for Female Urinary Incontinence)DESARROLLO E INVESTIGACION MEDICA ARAGONESA SLOTN2020-10-19
08437007606034Male Remeex System DESARROLLO E INVESTIGACION MEDICA ARAGONESA SLOTM2020-10-19
08437007606065KIM (Knotless Incontinence Mesh)DESARROLLO E INVESTIGACION MEDICA ARAGONESA SLOTN2020-10-19
08437007606072Remeex System -Readjustment kit DESARROLLO E INVESTIGACION MEDICA ARAGONESA SLOTN2020-10-19
08437007606232Male Remeex System - Readjustment kit DESARROLLO E INVESTIGACION MEDICA ARAGONESA SLOTM2020-10-19
08437007606263Remeex System - Thread PasserDESARROLLO E INVESTIGACION MEDICA ARAGONESA SLOTN2020-10-19
08437007606683KIM (Knotless Incontinence Mesh)DESARROLLO E INVESTIGACION MEDICA ARAGONESA SLOTN2020-10-19
00890594000858Desara Blue TVCaldera Medical, Inc.OTN2019-09-30
00890594000896DesaraCaldera Medical, Inc.OTN2019-09-30
00890594000902Desara TV Caldera Medical, Inc.OTN2019-09-30
00890594000841Desara Blue TVCALDERA MEDICAL, INC.OTN2019-09-30
00890594000889DesaraCALDERA MEDICAL, INC.OTN2019-09-30