Catalog Number

00-0182-04-WBNS

Brand Name

Smart Correction

Version/Model Number

00-0182-04-WBNS

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 30, 2022

Issuing Agency

In HIBCC

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

be1d4199-190e-403c-ac5d-6d88ed7e8f5d

Public Version Date

October 03, 2022

Public Version Number

2

DI Record Publish Date

May 11, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-