FDA.reportPublic FDA data

RHA® Dynamic Volume

Primary DI
07640173236283
Brand
RHA® Dynamic Volume
Company
Teoxane SA
Model
RHA® Dynamic Volume - TSK - US
Catalog number
940200
Device description
"""One box of RHA® Dynamic Volume contains two blisters and one instruction for use. Each blister contains a 1,2mL prefilled syringe and two needles (27G 1/2).Box Packaging (ID 07640173236276) is defined as unit of sales and identified with a serial number."""
Published
2025-12-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
07640173236276PackageGS12In Commercial Distribution
07640173236283PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640173236276076401732362767640173236276
07640173236283076401732362837640173236283

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.

Contacts#

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

Regulatory Flags#

DUNS number
482411860
Device count
1
Kit
true
Combination product
true
Lot or batch
true
Expiration date on label
true

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
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
07640173233411RHA® 4 MepiRHA® 4 Mepi - TSK - US9400332024-10-18

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Primary DI, Brand, Company table
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04262533320055JuvedermArcera GmbHLMH2026-05-08
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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
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
03770034301097RadiesseUNIVERDERMLMH2024-12-02