Male Remeex System - Readjustment kit

GUDID 08437007606232

DESARROLLO E INVESTIGACION MEDICA ARAGONESA SL

Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use

• Primary Device ID: 08437007606232
• NIH Device Record Key: 6da165a8-fd65-41cc-ba93-3579789421eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Male Remeex System - Readjustment kit
• Version Model Number: AR-01P
• Company DUNS: 513271056
• Company Name: DESARROLLO E INVESTIGACION MEDICA ARAGONESA SL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08437007606232 [Primary]

FDA Product Code

• OTM: Mesh, Surgical, For Stress Urinary Incontinence, Male

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-27
• Device Publish Date: 2020-10-19

Devices Manufactured by DESARROLLO E INVESTIGACION MEDICA ARAGONESA SL

• 08436568350141 - Anchorsure: 2020-10-27
• 08436568350882 - Remeex System -Readjustment kit Long: 2020-10-27
• 08436568350899 - Male Remeex System - Thread Passer: 2020-10-27
• 08437007606027 - Remeex System (for Female Urinary Incontinence): 2020-10-27
• 08437007606034 - Male Remeex System: 2020-10-27
• 08437007606058 - Needleless Sling: 2020-10-27
• 08437007606065 - KIM (Knotless Incontinence Mesh): 2020-10-27
• 08437007606072 - Remeex System -Readjustment kit: 2020-10-27