Geneva - Intrauterine Tube 70mm 15° - Nucletron B.V.

Duns Number:415269930

Device Description: Intrauterine Tube 70mm 15°

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


More Product Details

Catalog Number

-

Brand Name

Geneva

Version/Model Number

152011-00

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

-

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

K201272,K201272

Product Code Details

Product Code

JAQ

Product Code Name

System, applicator, radionuclide, remote-controlled

Device Record Status

Public Device Record Key

dd518f53-c699-4ba5-89d7-b8de1d4bb6dd

Public Version Date

August 21, 2020

Public Version Number

1

DI Record Publish Date

August 13, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NUCLETRON B.V." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1904