FDA.reportPublic FDA data

RHA® 3

Primary DI
07640173234166
Brand
RHA® 3
Company
Teoxane SA
Model
RHA® 3 US 1ml Schott/2 aig. TSK 27G1/2
Catalog number
940008/04
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 07640173234166) is defined as unit of sales and identified with a serial number."
Published
2024-03-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LMHImplant, Dermal, For Aesthetic Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LMHImplant, Dermal, For Aesthetic UseUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640173234166PackageGS12In Commercial Distribution
07640173234173PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640173234166076401732341667640173234166
07640173234173076401732341737640173234173

GMDN Terms#

Term, Definition table
TermDefinition
Dermal tissue reconstructive material, microbe-derived, anaestheticA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Special Storage Condition, Specify: Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
877-373-8669Medical-us@teoxane.com

Regulatory Flags#

DUNS number
482411860
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640173233763RHA® RedensityRHA® Redensity US 1ml Schott/2 aig. Terumo TW30G1/940056/012022-10-03
07640173233749RHA® 3RHA® 3 US 1ml Schott/2 aig. TSK 27G1/2940008/022022-10-03
07640173233732RHA® 2RHA® 2 US 1ml Schott/2 aig. TSK 30G1/2940007/022022-10-03
07640173236283RHA® Dynamic VolumeRHA® Dynamic Volume - TSK - US9402002025-12-18
07640173236276RHA® Dynamic VolumeRHA® Dynamic Volume - TSK - US9402002025-12-18
07640173233671RHA® 2RHA® 2 US 1ml Schott/2 aig. TSK 30G1/2940007/012022-06-10
07640173233688RHA® 3RHA® 3 US 1ml Schott/2 aig. TSK 27G1/2940008/012022-06-10
07640173234210RHA® 4RHA® 4 US 1.2ml Schott/2 aig. TSK 27G1/2940083/022023-09-15
07640173231653RHA® RedensityRHA® Redensity US 1ml Schott/2 aig. Terumo TW30G1/9400562022-05-03
07640173236177RHA® 3 MepiRHA® 3 Mepi - TSK - US9401952025-05-01
07640173236108RHA® 3 MepiRHA® 3 Mepi - TSK - US9401952025-05-01
07640173233756RHA® 4RHA® 4 US 1.2ml Schott/2 aig. TSK 27G1/2940083/012022-10-03
07640173230045RHA® 3RHA® 3 (1mL)9400082020-05-30
07640173230021RHA® 2RHA® 2 (1mL)9400072020-05-30
07640173230069RHA® 4RHA® 4 (1mL)9400092020-05-30
07640173233473RHA® 3 MepiRHA® 3 Mepi - TSK - US9400312024-10-18
07640173233480RHA® 4 MepiRHA® 4 Mepi - TSK - US9400332024-10-18
07640173233497RHA® Redensity™ MepiRHA® Redensity Mepi - Terumo - US9400342024-10-18
07640173233527RHA® 2 MepiRHA® 2 Mepi - Terumo - US9400992024-10-18
07640173233398RHA® 3 MepiRHA® 3 Mepi - TSK - US9400312024-10-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04262533320055JuvedermArcera GmbHLMH2026-05-08
04262533320062RestylaneArcera GmbHLMH2026-05-08
07331689120301Restylane Lyft with LidocaineQ-Med ABLMH2026-04-30
07331689120318Restylane Lyft with LidocaineQ-Med ABLMH2026-04-30
07331689120325Restylane EyelightQ-Med ABLMH2026-04-30
07331689120332Restylane EyelightQ-Med ABLMH2026-04-30
07331689120288Restylane-LQ-Med ABLMH2026-04-29
07331689120295Restylane-LQ-Med ABLMH2026-04-29
08437027710117SCULPTRASAIMA GLOBAL FARMA S.L.LMH2026-02-19
08437027710100SCULPTRASAIMA GLOBAL FARMA S.L.LMH2026-02-19
07640173236283RHA® Dynamic VolumeTeoxane SALMH2025-12-18
07640173236276RHA® Dynamic VolumeTeoxane SALMH2025-12-18
00362032907017saypha MagIQObagi Cosmeceuticals LLCLMH2025-11-27
00362032907024saypha MagIQ SAMPLEObagi Cosmeceuticals LLCLMH2025-11-27
07640123793309Belotero Balance LidocaineANTEIS SALMH2025-09-30
07640123793316Belotero Balance LidocaineANTEIS SALMH2025-09-30
08052570473434RadiesseDAMBO SRLLMH2025-09-25
08437027710063RESTYLANE DEFYNESAIMA GLOBAL FARMA S.L.LMH2025-06-30
08437027710070RESTYLANE KYSSESAIMA GLOBAL FARMA S.L.LMH2025-06-30
08437027710087RESTYLANE LYFT WITH LIDOCAINESAIMA GLOBAL FARMA S.L.LMH2025-06-30
08437027710094RESTYLANE REFYNESAIMA GLOBAL FARMA S.L.LMH2025-06-30
07640173236177RHA® 3 MepiTeoxane SALMH2025-05-01
07640173236108RHA® 3 MepiTeoxane SALMH2025-05-01
03760172161264EVOLYSSE FORMSYMATESELMH2025-02-19
03760172161271EVOLYSSE SMOOTHSYMATESELMH2025-02-19
03760172161288EVOLYSSE FORMSYMATESELMH2025-02-19
03760172161295EVOLYSSE FORMSYMATESELMH2025-02-19
03760172161301EVOLYSSE SMOOTHSYMATESELMH2025-02-19
03760172161318EVOLYSSE SMOOTHSYMATESELMH2025-02-19
03770034301103RadiesseUNIVERDERMLMH2024-12-02