Catalog Number

-

Brand Name

Caesar C

Version/Model Number

CM16160-00

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

K092338,K092338

Product Code

KNW

Product Code Name

Instrument, Biopsy

Public Device Record Key

7d16cf94-3e20-4676-a13e-37e0781f40cf

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 20, 2016

Package DI Number

18056515888007

Quantity per Package

10

Contains DI Package

08056515888000

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton Box