Coaptite M0068903000

GUDID 08714729804796

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

MERZ NORTH AMERICA, INC.

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• Primary Device ID: 08714729804796
• NIH Device Record Key: efacdaf4-c15e-4ada-a4f7-fef4c982c72d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Coaptite
• Version Model Number: 8005P10
• Catalog Number: M0068903000
• 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: false
• 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

Customer Support Contacts

• Phone: 888-272-1001
• Email: xxx@xxx.xxx
• Phone: 888-272-1001
• Email: xxx@xxx.xxx
• Phone: 888-272-1001
• Email: xxx@xxx.xxx
• Phone: 888-272-1001
• Email: xxx@xxx.xxx
• Phone: 888-272-1001
• Email: xxx@xxx.xxx
• Phone: 888-272-1001
• Email: xxx@xxx.xxx
• Phone: 888-272-1001
• Email: xxx@xxx.xxx
• Phone: 888-272-1001
• Email: xxx@xxx.xxx
• Phone: 888-272-1001
• Email: xxx@xxx.xxx
• Phone: 888-272-1001
• Email: xxx@xxx.xxx
• Phone: 888-272-1001
• Email: xxx@xxx.xxx
• Phone: 888-272-1001
• Email: xxx@xxx.xxx
• Phone: 888-272-1001
• Email: xxx@xxx.xxx
• Phone: 888-272-1001
• Email: xxx@xxx.xxx
• Phone: 888-272-1001
• Email: xxx@xxx.xxx

Device Dimensions

• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 90 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	08714729804796 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P040047

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-01-19
• Device Publish Date: 2014-09-17

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