Catalog Number

260-104-935

Brand Name

Guided Tray

Version/Model Number

260-104-935

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 16, 2019

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

-

Product Code

FSM

Product Code Name

Tray, Surgical, Instrument

Public Device Record Key

314a1911-6c68-4d89-9515-cda0c4f03502

Public Version Date

January 09, 2020

Public Version Number

4

DI Record Publish Date

June 10, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-