SteriTec 4/10 Load Challenge Test Pack - STERITEC PRODUCT MFG. CO., INC.

Duns Number:622223196

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More Product Details

Catalog Number

LT 111

Brand Name

SteriTec 4/10 Load Challenge Test Pack

Version/Model Number

LT 111

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

-

Product Code Details

Product Code

JOJ

Product Code Name

Indicator, Physical/Chemical Sterilization Process

Device Record Status

Public Device Record Key

81c6f58e-9499-4cc0-bbfd-0a189a28c288

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

10814434020247

Quantity per Package

40

Contains DI Package

00814434020240

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"STERITEC PRODUCT MFG. CO., INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 61