Catalog Number

-

Brand Name

EIT PLIF Instrument Tray

Version/Model Number

PEC00100

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

-

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

K170503

Product Code

FSM

Product Code Name

Tray, Surgical, Instrument

Public Device Record Key

17ef2efd-9fc4-435a-86e6-3be71a3a32fc

Public Version Date

July 08, 2021

Public Version Number

7

DI Record Publish Date

January 05, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-