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Prolaryn Gel Injectable Implant

FDA UDI

Class II (US FDA UDI)

by Merz North America, Inc.

Identity

Trade Name
Prolaryn Gel Injectable Implant FDA UDI
Generic Name
Injectable vocal cord medialization implant, synthetic FDA UDI
Device Name
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. FDA UDI
Model / Reference
8602M0K5 FDA UDI
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. FDA UDI

Identifiers

Primary DI / UDI-DI
M2138602M0K55 FDA UDI
510(k) Number
K060815 FDA UDI
FDA Product Code
MIX FDA UDI
GMDN Term
Injectable vocal cord medialization implant, synthetic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.3620 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Total Volume — 1.0 Milliliter FDA UDI

Category: Injectable vocal cord medialization implant, synthetic

Prolaryn Gel Injectable Implant by Merz North America, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Injectable vocal cord medialization implant, synthetic.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Merz North America, Inc.

Sources (1)

  • FDA UDI f6151d8a-dc07-4c6c-b00c-988b3077f244 37 fields · synced Jun 9, 2026