Catalog Number

95-6629

Brand Name

Regatta Lateral System

Version/Model Number

95-6629

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 29, 2022

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

FZT

Product Code Name

CUTTER, SURGICAL

Public Device Record Key

8bfb2d70-607e-4819-833f-db3a35719514

Public Version Date

April 29, 2022

Public Version Number

2

DI Record Publish Date

September 15, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-