Catalog Number

-

Brand Name

AED

Version/Model Number

HS2440

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

-

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

K141515

Product Code

HIH

Product Code Name

HYSTEROSCOPE (AND ACCESSORIES)

Public Device Record Key

3003a16b-49a8-4e39-8ed4-b51dc83017eb

Public Version Date

August 21, 2019

Public Version Number

2

DI Record Publish Date

May 07, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-