Prolaryn Gel Injectable Implant - Prolaryn Gel is a water-based injectable gel - MERZ NORTH AMERICA, INC.

Duns Number:028147846

Device Description: Prolaryn Gel is a water-based injectable gel implant used in the vocal folds to treat voca 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.

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More Product Details

Catalog Number

-

Brand Name

Prolaryn Gel Injectable Implant

Version/Model Number

8602M0K5

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

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"

Yes

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

K060815

Product Code Details

Product Code

MIX

Product Code Name

System, Vocal Cord Medialization

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

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MERZ NORTH AMERICA, INC." Characteristics
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