Identity
- Trade Name
- RHA® 2 FDA UDI
- Generic Name
- Dermal tissue reconstructive material, microbe-derived, anaesthetic FDA UDI
- Device Name
- One box of RHA® 2 contains two blisters and one instruction for use. Each blister contains a 1mL prefilled syringe and two needles (30G 1/2). Box Packaging (ID 07640173230014) is defined as unit of sales and identified with a serial number. FDA UDI
- Model / Reference
- RHA® 2 (1mL) FDA UDI
- Description
- One box of RHA® 2 contains two blisters and one instruction for use. Each blister contains a 1mL prefilled syringe and two needles (30G 1/2). Box Packaging (ID 07640173230014) is defined as unit of sales and identified with a serial number. FDA UDI
Identifiers
- Catalog Number
- 940007 FDA UDI
- Primary DI / UDI-DI
- 07640173230021 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
For aesthetic use, the RHA 2 device is a dermal tissue reconstructive material used to add volume and correct cutaneous contour deformities. It contains bacterial hyaluronic acid (HA) as its principal constituent and has been preloaded in disposable syringes with needles for safe injection.
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
- Teoxane SA
Sources (1)
- FDA UDI 44c28790-8951-43e2-a3ea-65e770739bac 37 fields · synced Jul 23, 2026