Catalog Number

3980

Brand Name

BOWIE-DICK TYPE TEST PACK pkg of 20 tests

Version/Model Number

3980

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

JOJ

Product Code Name

Indicator, physical/chemical sterilization process

Public Device Record Key

ed319110-b703-42c2-97e2-b6def72af208

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

M202398023

Quantity per Package

4

Contains DI Package

M202398012

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box