Catalog Number

-

Brand Name

Acu-Life (HE)

Version/Model Number

400531

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

-

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

OHY

Product Code Name

Pill Crusher/Cutter

Public Device Record Key

77b0d789-075b-4cdf-af48-28f5a39c1770

Public Version Date

September 18, 2020

Public Version Number

1

DI Record Publish Date

September 10, 2020

Package DI Number

10079573000622

Quantity per Package

144

Contains DI Package

00079573105313

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

cases