LumenCare Azure - LumenCare Azure Set 5F, 150cm - Nucletron B.V.

Duns Number:415269930

Device Description: LumenCare Azure Set 5F, 150cm

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More Product Details

Catalog Number

-

Brand Name

LumenCare Azure

Version/Model Number

110687-02

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K132874

Product Code Details

Product Code

JAQ

Product Code Name

System, applicator, radionuclide, remote-controlled

Device Record Status

Public Device Record Key

c78a57dc-34bb-4384-9a71-8d844bbb876d

Public Version Date

May 25, 2020

Public Version Number

1

DI Record Publish Date

May 16, 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