Catalog Number

102-0202

Brand Name

I-SIL Light Body HD Fast Set

Version/Model Number

102-0202

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

a0a31af7-1810-4692-b51e-83bf8502f9c4

Public Version Date

September 21, 2022

Public Version Number

8

DI Record Publish Date

February 20, 2017

Package DI Number

00020030918038

Quantity per Package

350

Contains DI Package

08809262959857

Package Discontinue Date

August 31, 2019

Package Status

Not in Commercial Distribution

Package Type

-