Catalog Number

-

Brand Name

Premium Plus

Version/Model Number

653-20GE

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"

-

For Single-Use

-

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

FSM

Product Code Name

Tray, Surgical, Instrument

Public Device Record Key

de29e9b4-494f-4019-b249-e1c6114e8b62

Public Version Date

September 16, 2022

Public Version Number

5

DI Record Publish Date

December 30, 2019

Package DI Number

D83865320GE8

Quantity per Package

2

Contains DI Package

D83865320GE6

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE