Catalog Number

1010

Brand Name

Aero-Med

Version/Model Number

1010

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"

Yes

For Single-Use

Yes

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

-

Product Code

HHT

Product Code Name

SPATULA, CERVICAL, CYTOLOGICAL

Public Device Record Key

17179918-bf0d-4b4b-8996-cef526140229

Public Version Date

February 21, 2019

Public Version Number

1

DI Record Publish Date

January 21, 2019

Package DI Number

50810010891001

Quantity per Package

10

Contains DI Package

10810010891003

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE