RHA® 3 Mepi 940031

GUDID 07640173233398

"One box of RHA® 3 Mepi contains two blisters and one instruction for use. Each blister contains a 1mL prefilled syringe and two needles (27G 1/2). Box Packaging (ID 07640173233398) is defined as unit of sales and identified with a serial number."

Teoxane SA

Dermal tissue reconstructive material, microbe-derived, anaesthetic
Primary Device ID07640173233398
NIH Device Record Key5d6a5ffa-3048-4ec1-9fa3-9468d1d02541
Commercial Distribution StatusIn Commercial Distribution
Brand NameRHA® 3 Mepi
Version Model NumberRHA® 3 Mepi - TSK - US
Catalog Number940031
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 *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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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.

Device Identifiers

Device Issuing AgencyDevice ID
GS107640173233398 [Package]
Contains: 07640173233473
Package: [2 Units]
In Commercial Distribution
GS107640173233473 [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 Date2024-10-28
Device Publish Date2024-10-18

Devices Manufactured by Teoxane SA

07640173233398 - RHA® 3 Mepi2024-10-28"One box of RHA® 3 Mepi contains two blisters and one instruction for use. Each blister contains a 1mL prefilled syringe and two needles (27G 1/2). Box Packaging (ID 07640173233398) is defined as unit of sales and identified with a serial number."
07640173233398 - RHA® 3 Mepi2024-10-28 "One box of RHA® 3 Mepi contains two blisters and one instruction for use. Each blister contains a 1mL prefilled syringe and t
07640173233411 - RHA® 4 Mepi2024-10-28 "One box of RHA® 4 Mepi contains two blisters and one instruction for use. Each blister contains a 1,2mL prefilled syringe and
07640173233367 - RHA® Redensity™ Mepi2024-10-28 "One box of RHA® Redensity™ Mepi contains two blisters and one instruction for use. Each blister contains a 1mL prefilled sy
07640173233442 - RHA® 2 Mepi2024-10-28 "One box of RHA® 2 Mepi contains two blisters and one instruction for use. Each blister contains a 1mL prefilled syringe and t
07640173234111 - RHA® 22024-04-01 "One box of RHA® 2 contains two blisters and one instruction for use. Each blister contains a 1mL prefilled syringe and two ne
07640173234166 - RHA® 32024-03-26 "One box of RHA® 3 contains two blisters and one instruction for use. Each blister contains a 1mL prefilled syringe and two ne
07640173234388 - RHA® 42023-10-24 "One box of RHA® 4 contains two blisters and one instruction for use. Each blister contains a 1,2mL prefilled syringe and two
07640173234197 - RHA® Redensity2023-09-25 "One box of RHA® Redensity contains two blisters and one instruction for use. Each blister contains a 1mL prefilled syringe an
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.