Varian POST ASSY, STEREOTACTIC HEAD FRAME - VARIAN MEDICAL SYSTEMS, INC.

Duns Number:009120817

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More Product Details

Catalog Number

-

Brand Name

Varian POST ASSY, STEREOTACTIC HEAD FRAME

Version/Model Number

10002738503

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

K180586,K180586

Product Code Details

Product Code

IYE

Product Code Name

Accelerator, linear, medical

Device Record Status

Public Device Record Key

71db7eda-88ba-47c9-8f32-743b3660bb8b

Public Version Date

March 01, 2021

Public Version Number

1

DI Record Publish Date

February 19, 2021

Additional Identifiers

Package DI Number

10899475002490

Quantity per Package

4

Contains DI Package

00899475002493

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"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