Catalog Number

205-212

Brand Name

Aveta Fluid Management Accessory

Version/Model Number

205-212

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

4b20eac4-4d84-4106-98ad-8f7f5a36d59e

Public Version Date

September 02, 2020

Public Version Number

1

DI Record Publish Date

August 25, 2020

Package DI Number

00850006759248

Quantity per Package

3

Contains DI Package

00850006759231

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

shelf carton