Identity
- Trade Name
- Restylane-L FDA UDI
- Generic Name
- Dermal tissue reconstructive material, microbe-derived, anaesthetic FDA UDI
- Model / Reference
- Gel 2.0 ml syringe FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07331689111767 FDA UDI
- PMA Number
- P040024 FDA UDI
- FDA Product Code
- LMH FDA UDI
- GMDN Term
- Dermal tissue reconstructive material, microbe-derived, anaesthetic FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
Restylane-L by Qmed, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
P040024 also covers:
- Restylane — Qmed, Inc.
- Restylane — Qmed, Inc.
- Restylane — Qmed, Inc.
- Restylane — Qmed, Inc.
- Restylane Eyelight — Qmed, Inc.
- Restylane Eyelight — Qmed, Inc.
- Restylane Lyft with Lidocaine — Qmed, Inc.
- Restylane Lyft with Lidocaine — Qmed, Inc.
- Restylane Lyft with Lidocaine — Qmed, Inc.
- Restylane Lyft with Lidocaine — Qmed, Inc.
- Restylane Lyft with Lidocaine — Qmed, Inc.
- Restylane Lyft with Lidocaine — Qmed, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Qmed, Inc.
Sources (1)
- FDA UDI 64adba67-6e30-493c-bc40-1c1e9b45617d 35 fields · synced Jun 8, 2026