AccessGUDID - DEVICE: Coaptite (10810235030645)

GUDID

Device Identifier (DI) Information

Brand Name: Coaptite
Version or Model: 8005M0
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MERZ NORTH AMERICA, INC.

Primary DI Number: 10810235030645
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 028147846 *Terms of Use

Device Description: The Coaptite Injectable implant is a permanently implanted device to treat women who have severe stress urinary incontinence due to poorly functioning urethral sphincter muscles

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LNM	Agent, Bulking, Injectable For Gastro-Urology Use

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 140021d7-e5b8-4271-94d3-b268052bb765
Public Version Date: October 23, 2024
Public Version Number: 1
DI Record Publish Date: October 15, 2024