Catalog Number

APDCSSG

Brand Name

AllPoints Dressing Change System

Version/Model Number

APDCSSG

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

FRO

Product Code Name

Dressing, wound, drug

Public Device Record Key

42062f4d-e0b0-4814-8722-c3c7bc5a50b2

Public Version Date

October 06, 2020

Public Version Number

4

DI Record Publish Date

February 26, 2016

Package DI Number

10801741123945

Quantity per Package

10

Contains DI Package

00801741123948

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA