Catalog Number

-

Brand Name

HydroBrader®

Version/Model Number

1922100

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

GFF

Product Code Name

BUR, SURGICAL, GENERAL & PLASTIC SURGERY

Public Device Record Key

d3c74863-2a3b-4cf0-a9d7-61e272bd1537

Public Version Date

February 15, 2021

Public Version Number

3

DI Record Publish Date

September 09, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-