Catalog Number

CF200-S

Brand Name

PerForm™

Version/Model Number

CF200-S

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

-

Product Code

EIY

Product Code Name

Instrument, Filling, Plastic, Dental

Public Device Record Key

64d1fe51-c61b-4dfc-b9b0-7ec2d48d12ac

Public Version Date

September 22, 2020

Public Version Number

2

DI Record Publish Date

April 24, 2020

Package DI Number

10810038093816

Quantity per Package

2

Contains DI Package

00810038093819

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CF200