Catalog Number

6411000

Brand Name

ACE

Version/Model Number

6411000

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

MMP

Product Code Name

Cover, barrier, protective

Public Device Record Key

a4477cb2-0066-4f53-9744-8a42014155a6

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 24, 2015

Package DI Number

10614950007056

Quantity per Package

10

Contains DI Package

00614950007059

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Tyvec Bag