NA - Cap, Ø 10 mm - Nucletron B.V.

Duns Number:415269930

Device Description: Cap, Ø 10 mm

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More Product Details

Catalog Number

-

Brand Name

NA

Version/Model Number

085117P01-00

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

-

Product Code Details

Product Code

JAQ

Product Code Name

System, applicator, radionuclide, remote-controlled

Device Record Status

Public Device Record Key

b5fe405b-7b31-44f7-9b81-bb34d4fa11c2

Public Version Date

February 07, 2019

Public Version Number

4

DI Record Publish Date

December 02, 2016

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