7D Navigated Brain Biopsy Needle - Izi Medical Products, LLC

Duns Number:933506164

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More Product Details

Catalog Number

-

Brand Name

7D Navigated Brain Biopsy Needle

Version/Model Number

MB3000-7D

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

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

K143241

Product Code Details

Product Code

HAW

Product Code Name

Neurological Stereotaxic Instrument

Device Record Status

Public Device Record Key

61b45de2-1f03-4b8a-9456-10f756df8497

Public Version Date

March 09, 2020

Public Version Number

1

DI Record Publish Date

February 28, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"IZI MEDICAL PRODUCTS, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 98
2 A medical device with a moderate to high risk that requires special controls. 518