Bravos HDR Ir 192 Brachytherapy Sealed Source - Varian Medical Systems Deutschland GmbH

Duns Number:332474605

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More Product Details

Catalog Number

VG32203000

Brand Name

Bravos HDR Ir 192 Brachytherapy Sealed Source

Version/Model Number

VG32203000

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K191580

Product Code Details

Product Code

JAQ

Product Code Name

System, applicator, radionuclide, remote-controlled

Device Record Status

Public Device Record Key

96af5507-baca-4f5a-8a64-4c59f470f187

Public Version Date

January 17, 2022

Public Version Number

1

DI Record Publish Date

January 09, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"VARIAN MEDICAL SYSTEMS DEUTSCHLAND GMBH" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 713