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 ID08714729804796
NIH Device Record Keyefacdaf4-c15e-4ada-a4f7-fef4c982c72d
Commercial Distribution StatusIn Commercial Distribution
Brand NameCoaptite
Version Model Number8005P10
Catalog NumberM0068903000
Company DUNS028147846
Company NameMERZ NORTH AMERICA, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone888-272-1001
Emailxxx@xxx.xxx
Phone888-272-1001
Emailxxx@xxx.xxx
Phone888-272-1001
Emailxxx@xxx.xxx
Phone888-272-1001
Emailxxx@xxx.xxx
Phone888-272-1001
Emailxxx@xxx.xxx
Phone888-272-1001
Emailxxx@xxx.xxx
Phone888-272-1001
Emailxxx@xxx.xxx
Phone888-272-1001
Emailxxx@xxx.xxx
Phone888-272-1001
Emailxxx@xxx.xxx
Phone888-272-1001
Emailxxx@xxx.xxx
Phone888-272-1001
Emailxxx@xxx.xxx
Phone888-272-1001
Emailxxx@xxx.xxx
Phone888-272-1001
Emailxxx@xxx.xxx
Phone888-272-1001
Emailxxx@xxx.xxx
Phone888-272-1001
Emailxxx@xxx.xxx

Device Dimensions

Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 90 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS108714729804796 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LNMAgent, Bulking, Injectable For Gastro-Urology Use

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-01-19
Device Publish Date2014-09-17

On-Brand Devices [Coaptite]

08714729804796The Coaptite Injectable Implant is a permanently implanted device used to treat women who have s
10810235030645The 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
COAPTITE
74603290 2222992 Live/Registered
MERZ NORTH AMERICA, INC.
1994-11-10

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