Catalog Number

-

Brand Name

CellaVision DC-1 PPA

Version/Model Number

XU-10302

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

-

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

K200595

Product Code

JOY

Product Code Name

Device, Automated Cell-Locating

Public Device Record Key

1437274f-d8b4-4d2e-9bab-e2b7f6e20940

Public Version Date

September 16, 2022

Public Version Number

2

DI Record Publish Date

October 22, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-