Length cutting gauge, 250mm for implant tubes and breast applicators up to 6 Fr. - Varian Medical Systems Deutschland GmbH

Duns Number:332474605

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More Product Details

Catalog Number

GM11010030

Brand Name

Length cutting gauge, 250mm for implant tubes and breast applicators up to 6 Fr.

Version/Model Number

GM11010030

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

K983436

Product Code Details

Product Code

JAQ

Product Code Name

System, applicator, radionuclide, remote-controlled

Device Record Status

Public Device Record Key

b9390183-2e9f-403c-bbd2-d585d75a5c14

Public Version Date

November 25, 2021

Public Version Number

1

DI Record Publish Date

November 17, 2021

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