Needleless Sling

GUDID 08437007606058

DESARROLLO E INVESTIGACION MEDICA ARAGONESA SL

Stress urinary incontinence surgical mesh, female
Primary Device ID08437007606058
NIH Device Record Key4f16d763-d163-407b-9909-f8cd00c25cb1
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeedleless Sling
Version Model NumberNL-01
Company DUNS513271056
Company NameDESARROLLO E INVESTIGACION MEDICA ARAGONESA SL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108437007606058 [Primary]

FDA Product Code

PAHMesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-27
Device Publish Date2020-10-19

Devices Manufactured by DESARROLLO E INVESTIGACION MEDICA ARAGONESA SL

08436568350141 - Anchorsure2020-10-27
08436568350882 - Remeex System -Readjustment kit Long2020-10-27
08436568350899 - Male Remeex System - Thread Passer2020-10-27
08437007606027 - Remeex System (for Female Urinary Incontinence)2020-10-27
08437007606034 - Male Remeex System 2020-10-27
08437007606058 - Needleless Sling2020-10-27
08437007606058 - Needleless Sling2020-10-27
08437007606065 - KIM (Knotless Incontinence Mesh)2020-10-27
08437007606072 - Remeex System -Readjustment kit 2020-10-27

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