Catalog Number

-

Brand Name

STRADIS HEALTHCARE

Version/Model Number

TP-SILICONE

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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"

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

MIB

Product Code Name

Elastomer, Silicone Block

Public Device Record Key

2a486236-6c95-4a01-9ad6-c0e4231532ee

Public Version Date

April 01, 2022

Public Version Number

1

DI Record Publish Date

March 24, 2022

Package DI Number

M752TPSILICONE1

Quantity per Package

1

Contains DI Package

M752TPSILICONE0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box