Catalog Number

102-0301

Brand Name

I-SIL Medium Body Regular Set

Version/Model Number

102-0301

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

1fe1cee4-edc9-4e79-b89d-2299a573684b

Public Version Date

September 22, 2022

Public Version Number

8

DI Record Publish Date

February 20, 2017

Package DI Number

02020030918043

Quantity per Package

350

Contains DI Package

08809262959819

Package Discontinue Date

September 30, 2019

Package Status

Not in Commercial Distribution

Package Type

-