Catalog Number

-

Brand Name

CHIBA

Version/Model Number

CH22200-01

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

KNW

Product Code Name

Instrument, Biopsy

Public Device Record Key

f9ca1102-e374-4c6a-9f44-ceb127fe38bb

Public Version Date

July 26, 2019

Public Version Number

1

DI Record Publish Date

July 18, 2019

Package DI Number

18055002905036

Quantity per Package

20

Contains DI Package

08055002905039

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-