Catalog Number

CCH2210

Brand Name

N/A

Version/Model Number

CCH2210

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

March 04, 2023

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

-

Product Code

KNW

Product Code Name

INSTRUMENT, BIOPSY

Public Device Record Key

98119afc-3aa0-4668-9ee9-b39718cb17c6

Public Version Date

July 12, 2019

Public Version Number

3

DI Record Publish Date

October 03, 2018

Package DI Number

50885403474369

Quantity per Package

5

Contains DI Package

10885403474361

Package Discontinue Date

March 04, 2023

Package Status

In Commercial Distribution

Package Type

Case