Remeex System - Passer Handle

GUDID 08437007606836

DESARROLLO E INVESTIGACION MEDICA ARAGONESA SL

Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting
Primary Device ID08437007606836
NIH Device Record Key8a4c6d79-37d2-4c13-be70-3b129a6b9c7b
Commercial Distribution StatusIn Commercial Distribution
Brand NameRemeex System - Passer Handle
Version Model NumberAR-05
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 Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108437007606836 [Primary]

FDA Product Code

OTNMesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08437007606836]

Moist Heat or Steam Sterilization


[08437007606836]

Moist Heat or Steam Sterilization


[08437007606836]

Moist Heat or Steam Sterilization


[08437007606836]

Moist Heat or Steam Sterilization


[08437007606836]

Moist Heat or Steam Sterilization


[08437007606836]

Moist Heat or Steam Sterilization


[08437007606836]

Moist Heat or Steam Sterilization


[08437007606836]

Moist Heat or Steam Sterilization


[08437007606836]

Moist Heat or Steam Sterilization


[08437007606836]

Moist Heat or Steam Sterilization


[08437007606836]

Moist Heat or Steam Sterilization


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
08437007606065 - KIM (Knotless Incontinence Mesh)2020-10-27
08437007606072 - Remeex System -Readjustment kit 2020-10-27

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