Catalog Number

415S120200

Brand Name

PrimoCut

Version/Model Number

415S120200

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

March 15, 2025

Issuing Agency

In GS1

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

-

Product Code

MJG

Product Code Name

DEVICE, PERCUTANEOUS, BIOPSY

Public Device Record Key

9b786a25-eeac-406e-b8d6-4cd2a7f2672a

Public Version Date

March 16, 2021

Public Version Number

4

DI Record Publish Date

December 15, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-