AccessGUDID - DEVICE: Prolaryn Gel Injectable Implant (M2138602M0K55)

GUDID

Device Identifier (DI) Information

Brand Name: Prolaryn Gel Injectable Implant
Version or Model: 8602M0K5
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MERZ NORTH AMERICA, INC.

Primary DI Number: M2138602M0K55
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 028147846 *Terms of Use

Device Description: Prolaryn Gel is a water-based injectable gel implant used in the vocal folds to treat vocal fold insuffiency. Prolaryn Gel resorbs within a period of 3-6 months and is a temporary implant.

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":	Yes
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?
42516	Injectable vocal cord medialization implant, synthetic	An implantable synthetic material [e.g., calcium hydroxyapatite, polytetrafluoroethylene (PTFE) -- commonly known as Teflon] designed as a space-occupying bulking agent to treat patients with unilateral vocal cord paralysis to improve voice quality. The device is typically available in a sterile syringe with needle, and is injected into the paralyzed vocal cord tissue, filling it and shifting it midline (vocal cord medialization). The properties of the device may facilitate ingrowth of the surrounding tissue over time. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MIX	System, Vocal Cord Medialization

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K060815	000

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
Storage Environment Temperature: between 59 and 90 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 1.0 Milliliter

Device Record Status

Public Device Record Key: f6151d8a-dc07-4c6c-b00c-988b3077f244
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 28, 2015