Catalog Number

301-H1126-2

Brand Name

Curaplex

Version/Model Number

301-H1126-2

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

CCW

Product Code Name

LARYNGOSCOPE, RIGID

Public Device Record Key

83cb440b-e29b-46b0-ad68-33670ffba01c

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

March 15, 2017

Package DI Number

00812574026108

Quantity per Package

20

Contains DI Package

00812574026092

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX