Catalog Number

PMI790-SCREW

Brand Name

PMI

Version/Model Number

PMI790-SCREW

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

-

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

GCL

Product Code Name

Esophagoscope, General & Plastic Surgery

Public Device Record Key

502b8ca0-1483-4d1c-bdc0-459c34320ea9

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 04, 2017

Package DI Number

10812608021588

Quantity per Package

10

Contains DI Package

00812608021581

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box