Catalog Number

214-251

Brand Name

Aveta Coral Disposable Hysteroscope

Version/Model Number

214-251

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K190372

Product Code

HIG

Product Code Name

Insufflator, Hysteroscopic

Public Device Record Key

8ca0ddb5-85e4-4e20-8a03-f7f6979ca9a1

Public Version Date

September 15, 2020

Public Version Number

1

DI Record Publish Date

September 07, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-