Remeex System - Thread Passer

GUDID 08437007606263

DESARROLLO E INVESTIGACION MEDICA ARAGONESA SL

Transvaginal needle, surgical

• Primary Device ID: 08437007606263
• NIH Device Record Key: a95a3beb-ef78-48c5-8835-2b024e2e1c8f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Remeex System - Thread Passer
• Version Model Number: AR-03
• 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	08437007606263 [Primary]

FDA Product Code

• OTN: Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

Sterilization

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

[08437007606263]

Moist Heat or Steam Sterilization

[08437007606263]

Moist Heat or Steam Sterilization

[08437007606263]

Moist Heat or Steam Sterilization

[08437007606263]

Moist Heat or Steam Sterilization

[08437007606263]

Moist Heat or Steam Sterilization

[08437007606263]

Moist Heat or Steam Sterilization

[08437007606263]

Moist Heat or Steam Sterilization

[08437007606263]

Moist Heat or Steam Sterilization

[08437007606263]

Moist Heat or Steam Sterilization

[08437007606263]

Moist Heat or Steam Sterilization

[08437007606263]

Moist Heat or Steam Sterilization

[08437007606263]

Moist Heat or Steam Sterilization

[08437007606263]

Moist Heat or Steam Sterilization

[08437007606263]

Moist Heat or Steam Sterilization

[08437007606263]

Moist Heat or Steam Sterilization

[08437007606263]

Moist Heat or Steam Sterilization

[08437007606263]

Moist Heat or Steam Sterilization

[08437007606263]

Moist Heat or Steam Sterilization

[08437007606263]

Moist Heat or Steam Sterilization

[08437007606263]

Moist Heat or Steam Sterilization

[08437007606263]

Moist Heat or Steam Sterilization

[08437007606263]

Moist Heat or Steam Sterilization

[08437007606263]

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
• 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