Catalog Number

-

Brand Name

Covers for air/water button and suction button. Biopsy port cover.

Version/Model Number

ASO4

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

JRJ

Product Code Name

Unit, Drying

Public Device Record Key

0d90ad4b-2c63-4c35-9fe8-22d50ba5474e

Public Version Date

October 10, 2022

Public Version Number

1

DI Record Publish Date

September 30, 2022

Package DI Number

10843356101833

Quantity per Package

100

Contains DI Package

00843356101836

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-