Coaptite

Basic Information

• Brand Name: Coaptite
• Primary DI: 08714729804796
• Version / Model: 8005P10
• Catalog Number: M0068903000
• Company Name: MERZ NORTH AMERICA, INC.
• Labeler DUNS: 028147846
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-17
• Public Version: 4
• Public Version Date: 2022-01-19
• Public Version Status: Update
• Public Device Record Key: efacdaf4-c15e-4ada-a4f7-fef4c982c72d

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LNM	Agent, Bulking, Injectable For Gastro-Urology Use	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
59133	Dermal tissue reconstructive material, synthetic mineral	A sterile, bioabsorbable, inorganic chemically synthesized mineral (e.g., synthesized calcium hydroxyapatite) intended to be injected into the dermis/hypodermis of the skin, lip submucosa, and/or for supraperiosteal administration to add volume by serving as a space-occupying supplement to the intercellular matrix of connective tissue (dermal filler), typically to correct cutaneous contour deformities (e.g., wrinkles, folds, scars) associated with aging, injury, or degenerative lesions; it does not include a local anaesthetic agent. The material is typically preloaded in a disposable syringe.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08714729804796	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P040047	000

Device Sizes

Type	Value	Unit	Text
Total Volume	1	Milliliter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 59 – 90 Degrees Fahrenheit