Identity
- Trade Name
- Restylane Defyne FDA UDI
- Generic Name
- Dermal tissue reconstructive material, microbe-derived, anaesthetic FDA UDI
- Model / Reference
- Gel 1 mL Syringe-Demo FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07331689116045 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
- 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, anaesthetic
Restylane Defyne 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, anaesthetic.
- JUVEDERM ULTRA XC — Allergan · Class III
- Juvederm Volbella — LAMBSMEAD LTD · Class III
- Revanesse Versa+ with Lidocaine 1.0 mL — Prollenium Medical
- RESTYLANE KYSSE — SAIMA GLOBAL FARMA S.L. · Class III
- JUVEDERM ULTRA PLUS XC 1ML SAMPLE — Allergan · Class III
- EVOLYSSE FORM — Symatese · Class III
- JUVEDERM VOLUX XC — Allergan · Class III
- JUVEDERM ULTRA XC — Allergan · Class III
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Qmed, Inc.
Sources (1)
- FDA UDI 489c9725-74bc-4815-b340-82d8b8616919 33 fields · synced May 31, 2026