Leak Stop Channel Marker Set, 1-12 - Includes one 25-pack of each Leak Stop Channel - Varian Medical Systems Deutschland GmbH

Duns Number:332474605

Device Description: Includes one 25-pack of each Leak Stop Channel Marker - Channels 1-12 with UDIs: 108163890 Includes one 25-pack of each Leak Stop Channel Marker - Channels 1-12 with UDIs: 10816389028507; 10816389028514; 10816389028521; 10816389028538; 10816389028545; 10816389028552; 10816389028569; 10816389028576; 10816389028583; 10816389028590; 10816389028606; 10816389028613;

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More Product Details

Catalog Number

GM11010510

Brand Name

Leak Stop Channel Marker Set, 1-12

Version/Model Number

GM11010510

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

Product Code Details

Product Code

JAQ

Product Code Name

System, applicator, radionuclide, remote-controlled

Device Record Status

Public Device Record Key

86afcef6-b73f-49ca-86d1-6b8d2f90003a

Public Version Date

June 27, 2022

Public Version Number

3

DI Record Publish Date

December 04, 2020

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