Catalog Number

-

Brand Name

BIOSUC-C7

Version/Model Number

BIO20100

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

K013108,K013108

Product Code

KNW

Product Code Name

Instrument, Biopsy

Public Device Record Key

9786cf7d-a9d1-4d26-9ec5-1c0049e3748e

Public Version Date

June 03, 2022

Public Version Number

5

DI Record Publish Date

September 23, 2016

Package DI Number

14526737120017

Quantity per Package

10

Contains DI Package

04526737120010

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-