Varian Universal Multi-channel Cylinder, 25mm diameter - VARIAN MEDICAL SYSTEMS, INC.

Duns Number:009120817

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More Product Details

Catalog Number

GM11011410

Brand Name

Varian Universal Multi-channel Cylinder, 25mm diameter

Version/Model Number

GM11011410

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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

K193240

Product Code Details

Product Code

JAQ

Product Code Name

System, applicator, radionuclide, remote-controlled

Device Record Status

Public Device Record Key

27c5bea2-961c-47dd-8ea1-d5097092714f

Public Version Date

March 03, 2021

Public Version Number

1

DI Record Publish Date

February 23, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"VARIAN MEDICAL SYSTEMS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5
2 A medical device with a moderate to high risk that requires special controls. 253