UNIVERSAL PLUS - Biopsy needle 18G x 200 mm - MEDAX SRL UNIPERSONALE

Duns Number:440211428

Device Description: Biopsy needle 18G x 200 mm

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More Product Details

Catalog Number

-

Brand Name

UNIVERSAL PLUS

Version/Model Number

UP18200-00

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"

Yes

For Single-Use

Yes

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

K092338,K092338

Product Code Details

Product Code

KNW

Product Code Name

Instrument, Biopsy

Device Record Status

Public Device Record Key

f742a98e-178c-40d8-8855-b912406e6b68

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

April 10, 2018

Additional Identifiers

Package DI Number

18056515880292

Quantity per Package

10

Contains DI Package

08056515880295

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"MEDAX SRL UNIPERSONALE" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 24
2 A medical device with a moderate to high risk that requires special controls. 436