Catalog Number

LCR-025

Brand Name

LANTOR CUBE BOWIE DICK TEST PACK

Version/Model Number

LCR-025

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K882756,K882756

Product Code

JOJ

Product Code Name

Indicator, physical/chemical sterilization process

Public Device Record Key

7e2d51a1-ca9b-4e35-b12c-df3c4b48f436

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

November 15, 2016

Package DI Number

50732224710148

Quantity per Package

10

Contains DI Package

10732224710140

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box