Catalog Number

102-0604

Brand Name

I-SiL Jumbo Heavy Body Fast Set

Version/Model Number

102-0604

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"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

ELW

Product Code Name

Material, Impression

Public Device Record Key

099e553b-ff6c-4d94-aa67-ca80dc7002fc

Public Version Date

September 21, 2022

Public Version Number

4

DI Record Publish Date

August 23, 2018

Package DI Number

02020072718045

Quantity per Package

20

Contains DI Package

08809262958065

Package Discontinue Date

May 16, 2019

Package Status

Not in Commercial Distribution

Package Type

-