Catalog Number

SC4011X

Brand Name

Monoject

Version/Model Number

SC4011X

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

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

K983187,K983187

Product Code

KNW

Product Code Name

INSTRUMENT, BIOPSY

Public Device Record Key

93f8258c-ef81-41cf-9025-61a7054ee8bb

Public Version Date

February 15, 2019

Public Version Number

6

DI Record Publish Date

October 14, 2016

Package DI Number

20884521021096

Quantity per Package

10

Contains DI Package

10884521021099

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK_OR_INNER_PACK