Catalog Number

-

Brand Name

Andwin

Version/Model Number

890181

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

K924908,K924908

Product Code

HHT

Product Code Name

Spatula, Cervical, Cytological

Public Device Record Key

bdf15503-69af-4950-a116-870789b58109

Public Version Date

May 30, 2019

Public Version Number

1

DI Record Publish Date

May 22, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-