Pushing device for implant needle, 1.7 mm diameter - for Flexible Interstitial Implant Tube Set, plus - VARIAN MEDICAL SYSTEMS, INC.

Duns Number:009120817

Device Description: for Flexible Interstitial Implant Tube Set, plus GM11008570-8580

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More Product Details

Catalog Number

GM11003040

Brand Name

Pushing device for implant needle, 1.7 mm diameter

Version/Model Number

GM11003040

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

K952913

Product Code Details

Product Code

JAQ

Product Code Name

System, applicator, radionuclide, remote-controlled

Device Record Status

Public Device Record Key

d31b1e19-48ef-4da0-863c-ecce1c4fd5be

Public Version Date

February 10, 2021

Public Version Number

1

DI Record Publish Date

February 02, 2021

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