Catalog Number

APDCSNB

Brand Name

AllPoints Dressing Change System

Version/Model Number

APDCSNB

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

-

Product Code

OXQ

Product Code Name

Dressing change tray

Public Device Record Key

6e8e5e0f-c4b8-4fd7-982b-6ae056bed930

Public Version Date

October 06, 2020

Public Version Number

4

DI Record Publish Date

February 29, 2016

Package DI Number

10801741123976

Quantity per Package

10

Contains DI Package

00801741123979

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA