Catalog Number

600-803-2A

Brand Name

AART Silicone Carving Block Sizer

Version/Model Number

A

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 26, 2017

Issuing Agency

In HIBCC

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"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K021820

Product Code

MIB

Product Code Name

ELASTOMER, SILICONE BLOCK

Public Device Record Key

fa310c86-72f6-49ab-8a82-a798bc64c960

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 20, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-