VariLoad Brachytherapy Kit I125 - Eckert & Ziegler Bebig, Inc.

Duns Number:021125001

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More Product Details

Catalog Number

VLKITI125

Brand Name

VariLoad Brachytherapy Kit I125

Version/Model Number

VariLoad Brachytherapy Kit I125

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)

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

-

Product Code Name

-

Device Record Status

Public Device Record Key

a42e0b54-f314-4e7a-b75e-4258580fbe6c

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 27, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ECKERT & ZIEGLER BEBIG, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 8
2 A medical device with a moderate to high risk that requires special controls. 7