Catalog Number

FHTPWB1

Brand Name

N/A

Version/Model Number

FHTPWB1

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

LXH

Product Code Name

Orthopedic Manual Surgical Instrument

Public Device Record Key

c8612a1b-c5ac-46c8-85dd-2924a9be8676

Public Version Date

May 13, 2022

Public Version Number

3

DI Record Publish Date

August 17, 2021

Package DI Number

00810045536248

Quantity per Package

10

Contains DI Package

00810004722149

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-