Catalog Number

GBF0115, GBF0215, GBF0315

Brand Name

BELLAFILL

Version/Model Number

1.5 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,P020012

Product Code

LMH

Product Code Name

Implant, Dermal, For Aesthetic Use

Public Device Record Key

9251ea54-60a7-47c5-948f-79c6a905b5a6

Public Version Date

September 21, 2022

Public Version Number

1

DI Record Publish Date

September 13, 2022

Package DI Number

10350224000148

Quantity per Package

3

Contains DI Package

00350224000141

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton