Catalog Number

-

Brand Name

ONETRAC LXD

Version/Model Number

C100270

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

GAD

Product Code Name

Retractor

Public Device Record Key

18b7cd91-88bd-4bcf-ba97-2cd217225b79

Public Version Date

October 13, 2020

Public Version Number

1

DI Record Publish Date

October 05, 2020

Package DI Number

M648C1002701

Quantity per Package

1

Contains DI Package

M648C1002700

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-