RHA® 3

Basic Information

• Brand Name: RHA® 3
• Primary DI: 07640173233688
• Version / Model: RHA® 3 US 1ml Schott/2 aig. TSK 27G1/2
• Catalog Number: 940008/01
• Company Name: Teoxane SA
• Labeler DUNS: 482411860
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-06-10
• Public Version: 3
• Public Version Date: 2023-11-17
• Public Version Status: Update
• Public Device Record Key: fd7dbeb8-42af-4fd5-b7a0-4eaaf1dbc5f5
• Distribution End Date: 2025-06-13

Device Description

"One box of RHA® 3 contains two blisters and one instruction for use. Each blister contains a 1mL prefilled syringe and two needles (27G 1/2). Box Packaging (ID 07640173233701) is defined as unit of sales and identified with a serial number."

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LMH	Implant, Dermal, For Aesthetic Use	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
47887	Dermal tissue reconstructive material, microbe-derived, anaesthetic	A sterile, bioabsorbable, bacteria-derived substance intended to be injected into the dermis/hypodermis of the skin, lip submucosa, and/or for supraperiosteal administration to add volume by serving as a space-occupying supplement to the intercellular matrix of connective tissue (dermal filler), typically to correct cutaneous contour deformities (e.g., wrinkles, folds, scars) associated with aging, injury, or degenerative lesions; it includes a local anaesthetic agent (e.g., lidocaine). It typically includes bacterial hyaluronic acid (HA) as the principal constituent and is typically preloaded in a disposable syringe; disposable needle(s)/cannula(e) dedicated to injection may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07640173233688	GS1
Package	07640173233701	GS1		2	In Commercial Distribution	2025-06-13

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze.