Catalog Number

-

Brand Name

TLC Self-Retaining Retractor Frame

Version/Model Number

ETLC500

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"

Yes

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

GAD

Product Code Name

Retractor

Public Device Record Key

01e31a99-189b-4ed8-8912-9b7bf3564f99

Public Version Date

October 31, 2018

Public Version Number

1

DI Record Publish Date

September 30, 2018

Package DI Number

00842071112264

Quantity per Package

1

Contains DI Package

00842071109721

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box (TLC500)