Catalog Number

GBF0208, GBF0508

Brand Name

BELLAFILL

Version/Model Number

1.0 cc

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

P020012,P020012,P020012

Product Code

LMH

Product Code Name

Implant, Dermal, For Aesthetic Use

Public Device Record Key

a1f7297f-4d4b-48de-92c6-3d05fd8391fc

Public Version Date

September 14, 2022

Public Version Number

6

DI Record Publish Date

December 01, 2014

Package DI Number

10350224000025

Quantity per Package

5

Contains DI Package

00350224000028

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

5 syringes per box