Cs-137 Tube Source - Cs-137, 62.5 mCi, sealed source - Eckert & Ziegler Isotope Products, Inc.

Duns Number:041668633

Device Description: Cs-137, 62.5 mCi, sealed source

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More Product Details

Catalog Number

67-6525

Brand Name

Cs-137 Tube Source

Version/Model Number

67-6525

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

-

Prescription Use (Rx)

Yes

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

KXK

Product Code Name

Source, Brachytherapy, Radionuclide

Device Record Status

Public Device Record Key

be960d4e-8a2c-4287-bb77-7a35b62272ec

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

March 29, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ECKERT & ZIEGLER ISOTOPE PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 7