AccessGUDID - DEVICE: Radiesse Volume Advantage (M2138071M0K25)

GUDID

Device Identifier (DI) Information

Brand Name: Radiesse Volume Advantage
Version or Model: 8071M0K2
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MERZ NORTH AMERICA, INC.

Primary DI Number: M2138071M0K25
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 028147846 *Terms of Use

Device Description: Radiesse Injectable Implant is a volumizing filler indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds and it is also intended for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus. Radiesse Volumizing Filler Kit contains (2) injectable implants and (4) 27 gauge thin walled x 0.75 inch needles.

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
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?
59133	Dermal tissue reconstructive material, synthetic mineral	A sterile, bioabsorbable, inorganic chemically synthesized mineral (e.g., synthesized calcium hydroxyapatite) 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 does not include a local anaesthetic agent. The material is typically preloaded in a disposable syringe.	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 [?]
P050037	000
P050052	000

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
Storage Environment Temperature: between 59 and 90 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 3.0 Milliliter

Device Record Status

Public Device Record Key: 244a3c19-4a8d-4efe-8a6c-52bc84b2ad63
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 09, 2016