Catalog Number

-

Brand Name

Acu-Life (HE)

Version/Model Number

400436/400436A

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)

Yes

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

NAB

Product Code Name

Gauze / Sponge,Nonresorbable For External Use

Public Device Record Key

cc83a21e-6ff2-41f0-98b9-6d8ea9e3af27

Public Version Date

September 18, 2020

Public Version Number

1

DI Record Publish Date

September 10, 2020

Package DI Number

10079573104368

Quantity per Package

12

Contains DI Package

00079573104361

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

bag