RHA® 4 - One box of RHA® 4 contains two blisters and one - Teoxane SA

Duns Number:482411860

Device Description: One box of RHA® 4 contains two blisters and one instruction for use. Each blister contains One box of RHA® 4 contains two blisters and one instruction for use. Each blister contains a 1mL prefilled syringe and two needles (27G 1/2).Box Packaging (ID 07640173230052) is defined as unit of sales and identified with a serial number.

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More Product Details

Catalog Number

940009

Brand Name

RHA® 4

Version/Model Number

RHA® 4 (1mL)

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

LMH

Product Code Name

Implant, Dermal, For Aesthetic Use

Device Record Status

Public Device Record Key

5d4dc483-9025-4cbc-b3f6-3ba9f5a63af9

Public Version Date

June 08, 2020

Public Version Number

1

DI Record Publish Date

May 30, 2020

Additional Identifiers

Package DI Number

07640173230052

Quantity per Package

2

Contains DI Package

07640173230069

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"TEOXANE SA" Characteristics
Device Class Device Class Description No of Devices
3 A medical device with high risk that requires premarket approval 5