RHA® 4 940083/02

GUDID 07640173234210

"One box of RHA® 4 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 07640173234203) is defined as unit of sales and identified with a serial number."

Teoxane SA

Dermal tissue reconstructive material, microbe-derived, anaesthetic

Primary Device ID	07640173234210
NIH Device Record Key	25dc43bc-1ff5-49c1-bed5-3151c41d89af
Commercial Distribution Status	In Commercial Distribution
Brand Name	RHA® 4
Version Model Number	RHA® 4 US 1.2ml Schott/2 aig. TSK 27G1/2
Catalog Number	940083/02
Company DUNS	482411860
Company Name	Teoxane SA
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

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

Operating and Storage Conditions

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640173234203 [Package] Package: [2 Units] Discontinued: 2025-05-27 In Commercial Distribution
GS1	07640173234210 [Primary]

FDA Product Code

LMH	Implant, Dermal, For Aesthetic Use

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2023-09-25
Device Publish Date	2023-09-15

On-Brand Devices [RHA® 4]

07640173230069	One box of RHA® 4 contains two blisters and one instruction for use. Each blister contains a 1
07640173232698	"One box of RHA® 4 contains two blisters and one instruction for use. Each blister contains a
07640173233756	"One box of RHA® 4 contains two blisters and one instruction for use. Each blister contains a
07640173234210	"One box of RHA® 4 contains two blisters and one instruction for use. Each blister contains a
07640173234388	"One box of RHA® 4 contains two blisters and one instruction for use. Each blister contains a

Special Storage Condition, Specify	Between 0 and 0 *Special Storage Condition, Specify: Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze.
Special Storage Condition, Specify	Between 0 and 0 *Special Storage Condition, Specify: Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze.
Special Storage Condition, Specify	Between 0 and 0 *Special Storage Condition, Specify: Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze.
Special Storage Condition, Specify	Between 0 and 0 *Special Storage Condition, Specify: Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze.
Special Storage Condition, Specify	Between 0 and 0 *Special Storage Condition, Specify: Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze.
Special Storage Condition, Specify	Between 0 and 0 *Special Storage Condition, Specify: Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze.
Special Storage Condition, Specify	Between 0 and 0 *Special Storage Condition, Specify: Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze.
Special Storage Condition, Specify	Between 0 and 0 *Special Storage Condition, Specify: Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze.
Special Storage Condition, Specify	Between 0 and 0 *Special Storage Condition, Specify: Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze.
Special Storage Condition, Specify	Between 0 and 0 *Special Storage Condition, Specify: Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze.
Special Storage Condition, Specify	Between 0 and 0 *Special Storage Condition, Specify: Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze.
Special Storage Condition, Specify	Between 0 and 0 *Special Storage Condition, Specify: Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze.
Special Storage Condition, Specify	Between 0 and 0 *Special Storage Condition, Specify: Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze.
Special Storage Condition, Specify	Between 0 and 0 *Special Storage Condition, Specify: Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze.
Special Storage Condition, Specify	Between 0 and 0 *Special Storage Condition, Specify: Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze.
Special Storage Condition, Specify	Between 0 and 0 *Special Storage Condition, Specify: Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze.
Special Storage Condition, Specify	Between 0 and 0 *Special Storage Condition, Specify: Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze.
Special Storage Condition, Specify	Between 0 and 0 *Special Storage Condition, Specify: Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze.
Special Storage Condition, Specify	Between 0 and 0 *Special Storage Condition, Specify: Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze.
Special Storage Condition, Specify	Between 0 and 0 *Special Storage Condition, Specify: Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze.
Special Storage Condition, Specify	Between 0 and 0 *Special Storage Condition, Specify: Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze.
Special Storage Condition, Specify	Between 0 and 0 *Special Storage Condition, Specify: Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze.
Special Storage Condition, Specify	Between 0 and 0 *Special Storage Condition, Specify: Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze.
Special Storage Condition, Specify	Between 0 and 0 *Special Storage Condition, Specify: Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze.
Special Storage Condition, Specify	Between 0 and 0 *Special Storage Condition, Specify: Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze.
Special Storage Condition, Specify	Between 0 and 0 *Special Storage Condition, Specify: Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze.
Special Storage Condition, Specify	Between 0 and 0 *Special Storage Condition, Specify: Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze.
Special Storage Condition, Specify	Between 0 and 0 *Special Storage Condition, Specify: Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze.
Special Storage Condition, Specify	Between 0 and 0 *Special Storage Condition, Specify: Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze.
Special Storage Condition, Specify	Between 0 and 0 *Special Storage Condition, Specify: Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze.
Special Storage Condition, Specify	Between 0 and 0 *Special Storage Condition, Specify: Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze.
Special Storage Condition, Specify	Between 0 and 0 *Special Storage Condition, Specify: Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze.
Special Storage Condition, Specify	Between 0 and 0 *Special Storage Condition, Specify: Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze.
Special Storage Condition, Specify	Between 0 and 0 *Special Storage Condition, Specify: Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze.