Mark - NON-REPOSITIONAL DISPOSABLE NEEDLE 20G x 150 mm - M.D.L. S.R.L.

Duns Number:447228586

Device Description: NON-REPOSITIONAL DISPOSABLE NEEDLE 20G x 150 mm FOR MAMMARY NODULE LOCALIZATION, WITH SING NON-REPOSITIONAL DISPOSABLE NEEDLE 20G x 150 mm FOR MAMMARY NODULE LOCALIZATION, WITH SINGLE HOOK

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More Product Details

Catalog Number

PN2015

Brand Name

Mark

Version/Model Number

PN2015

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 26, 2021

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

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

-

Product Code Details

Product Code

GDF

Product Code Name

Guide, Needle, Surgical

Device Record Status

Public Device Record Key

aba51127-344b-4c9c-9fc9-10719a7ae228

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

April 26, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"M.D.L. S.R.L." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 228
2 A medical device with a moderate to high risk that requires special controls. 138