AccessGUDID - DEVICE: RHA® 2 (07640173234128)

GUDID

Device Identifier (DI) Information

Brand Name: RHA® 2
Version or Model: RHA® 2 - Terumo - US
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 940103
Company Name: Teoxane SA

Primary DI Number: 07640173234128
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 482411860 *Terms of Use

Device Description: "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."

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47887	Dermal tissue reconstructive material, microbe-derived, anaesthetic	A 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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LMH	Implant, Dermal, For Aesthetic Use

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1be3e6b9-7bdc-427f-af65-003127c22ace
Public Version Date: April 01, 2024
Public Version Number: 1
DI Record Publish Date: March 22, 2024