Catalog Number

-

Brand Name

Andwin Scientific

Version/Model Number

230075

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

K890283,K890283,K890283

Product Code

HHT

Product Code Name

Spatula, Cervical, Cytological

Public Device Record Key

294d9549-4a13-4701-b5f1-0321541a09ee

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 02, 2017

Package DI Number

20187207000140

Quantity per Package

20

Contains DI Package

10187207000143

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE