Coaptite

GUDID 10810235030645

The Coaptite Injectable implant is a permanently implanted device to treat women who have severe stress urinary incontinence due to poorly functioning urethral sphincter muscles

MERZ NORTH AMERICA, INC.

Dermal tissue reconstructive material, synthetic mineral

• Primary Device ID: 10810235030645
• NIH Device Record Key: 140021d7-e5b8-4271-94d3-b268052bb765
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Coaptite
• Version Model Number: 8005M0
• Company DUNS: 028147846
• Company Name: MERZ NORTH AMERICA, INC.
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10810235030645 [Primary]

FDA Product Code

• LNM: Agent, Bulking, Injectable For Gastro-Urology Use

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: 2024-10-23
• Device Publish Date: 2024-10-15

On-Brand Devices [Coaptite]

• 08714729804796: The Coaptite Injectable Implant is a permanently implanted device used to treat women who have s
• 10810235030645: The Coaptite Injectable implant is a permanently implanted device to treat women who have severe