Getinge Blue Sterilization Indicator Tape 1" - STERITEC PRODUCT MFG. CO., INC.

Duns Number:622223196

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More Product Details

Catalog Number

61301600046

Brand Name

Getinge Blue Sterilization Indicator Tape 1"

Version/Model Number

61301600046

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 01, 2022

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)

Yes

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

a5cedd5f-fa3c-4768-a5a4-49fe23d3c12e

Public Version Date

August 01, 2022

Public Version Number

4

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

10814434020360

Quantity per Package

36

Contains DI Package

00814434020363

Package Discontinue Date

August 01, 2022

Package Status

Not 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