RHA® 2 940103

GUDID 07640173234111

"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 07640173234111) is defined as unit of sales and identified with a serial number."

Teoxane SA

Dermal tissue reconstructive material, microbe-derived, anaesthetic Dermal tissue reconstructive material, microbe-derived, anaesthetic Dermal tissue reconstructive material, microbe-derived, anaesthetic Dermal tissue reconstructive material, microbe-derived, anaesthetic Dermal tissue reconstructive material, microbe-derived, anaesthetic Dermal tissue reconstructive material, microbe-derived, anaesthetic Dermal tissue reconstructive material, microbe-derived, anaesthetic Dermal tissue reconstructive material, microbe-derived, anaesthetic Dermal tissue reconstructive material, microbe-derived, anaesthetic Dermal tissue reconstructive material, microbe-derived, anaesthetic Dermal tissue reconstructive material, microbe-derived, anaesthetic Dermal tissue reconstructive material, microbe-derived, anaesthetic
Primary Device ID07640173234111
NIH Device Record Key1be3e6b9-7bdc-427f-af65-003127c22ace
Commercial Distribution StatusIn Commercial Distribution
Brand NameRHA® 2
Version Model NumberRHA® 2 - Terumo - US
Catalog Number940103
Company DUNS482411860
Company NameTeoxane SA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Producttrue
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone877-373-8669
EmailMedical-us@teoxane.com
Phone877-373-8669
EmailMedical-us@teoxane.com
Phone877-373-8669
EmailMedical-us@teoxane.com
Phone877-373-8669
EmailMedical-us@teoxane.com
Phone877-373-8669
EmailMedical-us@teoxane.com
Phone877-373-8669
EmailMedical-us@teoxane.com
Phone877-373-8669
EmailMedical-us@teoxane.com
Phone877-373-8669
EmailMedical-us@teoxane.com
Phone877-373-8669
EmailMedical-us@teoxane.com
Phone877-373-8669
EmailMedical-us@teoxane.com
Phone877-373-8669
EmailMedical-us@teoxane.com
Phone877-373-8669
EmailMedical-us@teoxane.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS107640173234111 [Package]
Contains: 07640173234128
Package: box [2 Units]
In Commercial Distribution
GS107640173234128 [Primary]

FDA Product Code

LMHImplant, Dermal, For Aesthetic Use

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-01
Device Publish Date2024-03-22

On-Brand Devices [RHA® 2]

07640173230021One box of RHA® 2 contains two blisters and one instruction for use. Each blister contains a 1
07640173233671"One box of RHA® 2 contains two blisters and one instruction for use. Each blister contains a
07640173233732"One box of RHA® 2 contains two blisters and one instruction for use. Each blister contains a
07640173234234"One box of RHA® 2 contains two blisters and one instruction for use. Each blister contains a
07640173234111"One box of RHA® 2 contains two blisters and one instruction for use. Each blister contains a
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