Catalog Number

72205104

Brand Name

ACUFEX

Version/Model Number

72205104

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

KQZ

Product Code Name

COMPONENT, TRACTION, NON-INVASIVE

Public Device Record Key

1eae2b1d-94ea-4fb1-997b-eb92b92162ac

Public Version Date

December 17, 2018

Public Version Number

1

DI Record Publish Date

November 16, 2018

Package DI Number

20885556714120

Quantity per Package

6

Contains DI Package

00885556714126

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX