Catalog Number

SM4340-1

Brand Name

ProChek ID

Version/Model Number

SM4340

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"

-

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

K951113,K951113,K951113

Product Code

LRT

Product Code Name

Indicator, Sterilization

Public Device Record Key

d6022317-8a0b-4fa1-8d5d-d29ba97dd894

Public Version Date

November 01, 2022

Public Version Number

6

DI Record Publish Date

September 23, 2016

Package DI Number

H816SM43402

Quantity per Package

6

Contains DI Package

H816SM43401

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case Box