Nox W7 Link Kit - S - Nox Medical ehf.

Duns Number:365741462

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More Product Details

Catalog Number

544010

Brand Name

Nox W7 Link Kit - S

Version/Model Number

NOX-BTUNI_S

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 12, 2022

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

OUG

Product Code Name

Medical Device Data System

Device Record Status

Public Device Record Key

4c0f3ea9-485d-4185-b5ec-541de493483a

Public Version Date

April 14, 2022

Public Version Number

2

DI Record Publish Date

February 24, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NOX MEDICAL EHF." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 11
2 A medical device with a moderate to high risk that requires special controls. 58