Catalog Number

AlloX-12E

Brand Name

AlloX Tissue Expander

Version/Model Number

AlloX-12E

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 11, 2016

Issuing Agency

In HIBCC

MRI safety Status

MR Unsafe

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

-

Product Code

LCJ

Product Code Name

Expander, Skin, Inflatable

Public Device Record Key

5f8ef91e-0e72-4512-8f43-48de59d09daf

Public Version Date

September 23, 2019

Public Version Number

4

DI Record Publish Date

September 15, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-