Duns Number:028147846
Device Description: The Coaptite Injectable Implant is a permanently implanted device used to treat women who 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.
Catalog Number
M0068903000
Brand Name
Coaptite
Version/Model Number
8005P10
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
P040047
Product Code
LNM
Product Code Name
Agent, Bulking, Injectable For Gastro-Urology Use
Public Device Record Key
efacdaf4-c15e-4ada-a4f7-fef4c982c72d
Public Version Date
January 19, 2022
Public Version Number
4
DI Record Publish Date
September 17, 2014
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |
| 3 | A medical device with high risk that requires premarket approval | 8 |