Overlay - Varian Exact™ Couch Indexing Bar-53cm - DIACOR, INC.

Duns Number:605813559

Device Description: Varian Exact™ Couch Indexing Bar-53cm

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Overlay

Version/Model Number

MIB-1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

IYE

Product Code Name

Accelerator, Linear, Medical

Device Record Status

Public Device Record Key

98e34bc2-2424-4465-afeb-6705ce9a02ea

Public Version Date

February 01, 2021

Public Version Number

1

DI Record Publish Date

January 22, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DIACOR, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 23
2 A medical device with a moderate to high risk that requires special controls. 107