Leak Stop Channel Marker - Channel 24 - 25 pack - VARIAN MEDICAL SYSTEMS, INC.

Duns Number:009120817

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More Product Details

Catalog Number

Not Sold Separately

Brand Name

Leak Stop Channel Marker - Channel 24 - 25 pack

Version/Model Number

Channel 24

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K152018,K152018

Product Code Details

Product Code

JAQ

Product Code Name

System, applicator, radionuclide, remote-controlled

Device Record Status

Public Device Record Key

072f8ce2-a164-4642-9f18-ab46e0606af1

Public Version Date

December 18, 2020

Public Version Number

2

DI Record Publish Date

November 11, 2020

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