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Restylane

FDA UDI

Class III (US FDA UDI)

by Qmed, Inc.

Identity

Trade Name
Restylane FDA UDI
Generic Name
Dermal tissue reconstructive material, microbe-derived FDA UDI
Model / Reference
Gel 1 mL Syringe FDA UDI

Identifiers

Primary DI / UDI-DI
00302995969141 FDA UDI
PMA Number
P040024 FDA UDI
FDA Product Code
LMH FDA UDI
GMDN Term
Dermal tissue reconstructive material, microbe-derived 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

No

FDA UDI

Combination Product

Yes

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

Category: Dermal tissue reconstructive material, microbe-derived

Restylane by Qmed, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dermal tissue reconstructive material, microbe-derived.

Cleared under the same submission

P040024 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Qmed, Inc.

Sources (1)

  • FDA UDI 1944ec4e-e9d4-4753-b5a7-fbdeca1a30da 34 fields · synced May 30, 2026