Catalog Number

TRB-1F

Brand Name

NA

Version/Model Number

TRB-1F

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

K153243

Product Code

HAE

Product Code Name

Rongeur, Manual

Public Device Record Key

fdc531f0-1c7b-4940-8700-ee0e7751814a

Public Version Date

July 17, 2019

Public Version Number

2

DI Record Publish Date

April 11, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-