Catalog Number

220-2002

Brand Name

Aveta Opal Disposable Hysteroscope, 4.6mm

Version/Model Number

220-2002

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,K190372

Product Code

HIG

Product Code Name

Insufflator, Hysteroscopic

Public Device Record Key

ba3c91ae-2446-43f7-b493-eb63384cd370

Public Version Date

July 01, 2021

Public Version Number

1

DI Record Publish Date

June 23, 2021

Package DI Number

00850006759576

Quantity per Package

6

Contains DI Package

00850006759569

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

shelf carton