Catalog Number

CV4000

Brand Name

CRYSTALVIEW

Version/Model Number

CV4000

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 11, 2021

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

K182882,K182882,K182882

Product Code

HRX

Product Code Name

Arthroscope

Public Device Record Key

6d5f958c-127d-4e2f-85f1-b6d533ddc22c

Public Version Date

May 12, 2021

Public Version Number

2

DI Record Publish Date

August 24, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-