Catalog Number

1-016409

Brand Name

Acu-Flow™ Rigid Tray

Version/Model Number

1-016409

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K053018

Product Code

ELW

Product Code Name

MATERIAL, IMPRESSION

Public Device Record Key

918ac5eb-ccd5-4b19-b2e8-59cf3170a077

Public Version Date

August 04, 2021

Public Version Number

1

DI Record Publish Date

July 27, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-