Male Remeex System - Thread Passer

GUDID 08436568350899

DESARROLLO E INVESTIGACION MEDICA ARAGONESA SL

Transvaginal needle, surgical Transvaginal needle, surgical Transvaginal needle, surgical Transvaginal needle, surgical Transvaginal needle, surgical Transvaginal needle, surgical Transvaginal needle, surgical Transvaginal needle, surgical Transvaginal needle, surgical Transvaginal needle, surgical Transvaginal needle, surgical

• Primary Device ID: 08436568350899
• NIH Device Record Key: 0998e3c3-3787-4a36-87d5-003fe156e3da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Male Remeex System - Thread Passer
• Version Model Number: AR-07
• 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: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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	08436568350899 [Primary]

FDA Product Code

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

Sterilization

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

[08436568350899]

Moist Heat or Steam Sterilization

[08436568350899]

Moist Heat or Steam Sterilization

[08436568350899]

Moist Heat or Steam Sterilization

[08436568350899]

Moist Heat or Steam Sterilization

[08436568350899]

Moist Heat or Steam Sterilization

[08436568350899]

Moist Heat or Steam Sterilization

[08436568350899]

Moist Heat or Steam Sterilization

[08436568350899]

Moist Heat or Steam Sterilization

[08436568350899]

Moist Heat or Steam Sterilization

[08436568350899]

Moist Heat or Steam Sterilization

[08436568350899]

Moist Heat or Steam Sterilization

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
• 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