Catalog Number

SW305

Brand Name

Aurora Hydrocolloide Adhesive Sheath

Version/Model Number

SW305

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

NNX

Product Code Name

DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE

Public Device Record Key

d3d21142-d052-47bd-bb82-3d8abe1869a6

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

September 22, 2020

Package DI Number

20801741072103

Quantity per Package

360

Contains DI Package

10801741072106

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA