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Prolaryn Plus Injectable Implant

FDA UDI

Class II (US FDA UDI)

by Merz North America, Inc.

Identity

Trade Name
Prolaryn Plus Injectable Implant FDA UDI
Generic Name
Injectable vocal cord medialization implant, synthetic FDA UDI
Device Name
Prolaryn Plus is a water based injectable gel implant used to treat vocal fold insufficiency. The principle component of Prolaryn Plus is synthetic calcium hydroxyapatite, a biomaterial found in bone and teeth. Injection with Prolaryn Plus augments or bulks ups the displaced or damaged vocal fold so that it can improve speaking. The result is long term restoration and augmentation. Prolaryn Plus can be injected with a 26 gauge or larger diameter thin-wall-needle. FDA UDI
Model / Reference
8044M0K5 FDA UDI
Description
Prolaryn Plus is a water based injectable gel implant used to treat vocal fold insufficiency. The principle component of Prolaryn Plus is synthetic calcium hydroxyapatite, a biomaterial found in bone and teeth. Injection with Prolaryn Plus augments or bulks ups the displaced or damaged vocal fold so that it can improve speaking. The result is long term restoration and augmentation. Prolaryn Plus can be injected with a 26 gauge or larger diameter thin-wall-needle. FDA UDI

Identifiers

Primary DI / UDI-DI
M2138044M0K55 FDA UDI
510(k) Number
K013243 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 Plus 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 a5cc15b6-457e-4004-acf3-a9118a42ceca 37 fields · synced Jun 9, 2026