Catalog Number

-

Brand Name

Safetex

Version/Model Number

890076

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K983428,K983428,K983428

Product Code

HHT

Product Code Name

Spatula, Cervical, Cytological

Public Device Record Key

dd066217-d2cf-4c30-8054-867a873997d2

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 01, 2017

Package DI Number

20187207000232

Quantity per Package

5

Contains DI Package

00187207000238

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE