Catalog Number

X31-400023

Brand Name

Exact™ Integral® Instrumentation

Version/Model Number

X31-400023

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

HTO

Product Code Name

REAMER

Public Device Record Key

3e6310b4-73dd-418c-8a4a-30ae3a545429

Public Version Date

May 16, 2022

Public Version Number

1

DI Record Publish Date

May 08, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-