Catalog Number

-

Brand Name

Andwin Scientific

Version/Model Number

210070

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,K930955,K890283,K930955

Product Code

HHT

Product Code Name

Spatula, Cervical, Cytological

Public Device Record Key

3f6b0997-f11a-46a4-a2a0-7c60fc2b9fb7

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 02, 2017

Package DI Number

10187207000204

Quantity per Package

100

Contains DI Package

00187207000207

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE