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Radiesse Moderate Fill 0.8cc

FDA UDI

Class III (US FDA UDI)

by Merz North America, Inc.

Identity

Trade Name
Radiesse Moderate Fill 0.8cc FDA UDI
Generic Name
Dermal tissue reconstructive material, synthetic mineral FDA UDI
Device Name
Radiesse Injectable Implant is a volumizing filler indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds and it is also intended for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus. Radiesse Volumizing Filler Kit contains (1) injectable implant and (2) 27 gauge thin walled x 0.75 inch needles. FDA UDI
Model / Reference
8069M0K1 FDA UDI
Description
Radiesse Injectable Implant is a volumizing filler indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds and it is also intended for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus. Radiesse Volumizing Filler Kit contains (1) injectable implant and (2) 27 gauge thin walled x 0.75 inch needles. FDA UDI

Identifiers

Primary DI / UDI-DI
M2138069M0K15 FDA UDI
PMA Number
P050037 FDA UDI
P050052 FDA UDI
FDA Product Code
LMH FDA UDI
GMDN Term
Dermal tissue reconstructive material, synthetic mineral FDA UDI

Classification

Device Class
Class III 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 — 0.8 Milliliter FDA UDI

Category: Dermal tissue reconstructive material, synthetic mineral

Radiesse Moderate Fill 0.8cc by Merz North America, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dermal tissue reconstructive material, synthetic mineral.

Cleared under the same submission

P050037 also covers:

P050052 also covers:

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 9f91ee2c-4a64-4ce1-9f31-70bb0dcc435c 37 fields · synced Jun 9, 2026