Catalog Number

212-205

Brand Name

Aveta Roll Stand with Drape Pump

Version/Model Number

212-205

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

-

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

a38e7b29-8da1-46d7-922f-024c129e144d

Public Version Date

August 09, 2021

Public Version Number

2

DI Record Publish Date

November 26, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-