NA - Oncentra External Beam Oncentra Brachy v4.6.1 - Nucletron B.V.

Duns Number:415269930

Device Description: Oncentra External Beam Oncentra Brachy v4.6.1

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More Product Details

Catalog Number

-

Brand Name

NA

Version/Model Number

170607-00

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K121448,K132816

Product Code Details

Product Code

MUJ

Product Code Name

System, planning, radiation therapy treatment

Device Record Status

Public Device Record Key

b2b94d2d-e493-4b91-8f67-865b4abf8488

Public Version Date

October 20, 2021

Public Version Number

1

DI Record Publish Date

October 12, 2021

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