Needleless Sling

Primary DI
08437007606058
Brand
Needleless Sling
Company
DESARROLLO E INVESTIGACION MEDICA ARAGONESA SL
Model
NL-01
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
PAHMesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PAHMesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-SlingGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08437007606058PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08437007606058084370076060588437007606058

GMDN Terms#

Term, Definition table
TermDefinition
Stress urinary incontinence surgical mesh, femaleA sterile woven/knitted or porous material made of non-bioabsorbable synthetic polymer (e.g., polypropylene) intended to be permanently implanted (via transobturator, transvaginal, retropubic or suprapubic approach) to support the urethra for the treatment of female stress urinary incontinence (SUI), resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). It typically includes an integral adjustment suture which may contain bioabsorbable polymer materials. It may be referred to as a sling, tape, or subfascial hammock, and may be pre-configured or cut to a desired size/shape. Disposable devices associated with implantation (e.g., needles, sheaths) may be included.

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
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
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00890594000971Desara One Caldera Medical, Inc.PAH2020-02-25
08714729961901Solyx™ BlueBOSTON SCIENTIFIC CORPORATIONPAH2018-06-13
28032919892120T-SLINGHERNIAMESH SRLPAH2016-08-05
00814723020036MiniArcENDO PHARMACEUTICALS INC.PAH2015-10-24
00814723020104MiniArcENDO PHARMACEUTICALS INC.PAH2015-10-24
00814723020364MiniArcENDO PHARMACEUTICALS INC.PAH2015-10-24
05708932467407AltisColoplast A/SPAH2015-10-22
08714729774044Solyx™ SIS SystemBOSTON SCIENTIFIC CORPORATIONPAH2015-09-24
08714729784784Solyx™ SIS System BOSTON SCIENTIFIC CORPORATIONPAH2015-09-24