Catalog Number

0031400

Brand Name

ACE

Version/Model Number

0031400

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FPX

Product Code Name

Strip, adhesive, closure, skin

Public Device Record Key

62b67d2b-9169-4014-b7bb-e70219af7633

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

July 05, 2017

Package DI Number

10614950009159

Quantity per Package

50

Contains DI Package

00614950009152

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box