Getinge Assured Green Tape 18mm (Steam) - STERITEC PRODUCT MFG. CO., INC.

Duns Number:622223196

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More Product Details

Catalog Number

6001154902

Brand Name

Getinge Assured Green Tape 18mm (Steam)

Version/Model Number

6001154902

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 25, 2018

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

K122555,K122555

Product Code Details

Product Code

JOJ

Product Code Name

Indicator, Physical/Chemical Sterilization Process

Device Record Status

Public Device Record Key

d3281b47-fa82-4b17-9736-2d0c418e5294

Public Version Date

September 26, 2018

Public Version Number

4

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

10814434020438

Quantity per Package

48

Contains DI Package

00814434020431

Package Discontinue Date

September 25, 2018

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