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.
Dermal tissue reconstructive material, synthetic mineral| 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 |
| xxx@xxx.xxx | |
| Phone | 888-272-1001 |
| xxx@xxx.xxx | |
| Phone | 888-272-1001 |
| xxx@xxx.xxx | |
| Phone | 888-272-1001 |
| xxx@xxx.xxx | |
| Phone | 888-272-1001 |
| xxx@xxx.xxx | |
| Phone | 888-272-1001 |
| xxx@xxx.xxx | |
| Phone | 888-272-1001 |
| xxx@xxx.xxx | |
| Phone | 888-272-1001 |
| xxx@xxx.xxx | |
| Phone | 888-272-1001 |
| xxx@xxx.xxx | |
| Phone | 888-272-1001 |
| xxx@xxx.xxx | |
| Phone | 888-272-1001 |
| xxx@xxx.xxx | |
| Phone | 888-272-1001 |
| xxx@xxx.xxx | |
| Phone | 888-272-1001 |
| xxx@xxx.xxx | |
| Phone | 888-272-1001 |
| xxx@xxx.xxx | |
| Phone | 888-272-1001 |
| 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 |
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 |
Trademark Results [Coaptite]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 COAPTITE 74603290 2222992 Live/Registered |
MERZ NORTH AMERICA, INC. 1994-11-10 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.