Catalog Number

DIA CAYA USA

Brand Name

Caya contoured diaphragm

Version/Model Number

Caya contoured diaphragm

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K140305

Product Code

HDW

Product Code Name

Diaphragm, Contraceptive (And Accessories)

Public Device Record Key

2f61e32f-6e04-4c37-a6e7-5a5761c04996

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 09, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-