Catalog Number

01-8323

Brand Name

N/A

Version/Model Number

01-8323

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

-

Product Code

GEG

Product Code Name

ELEVATOR, SURGICAL, GENERAL & PLASTIC SURGERY

Public Device Record Key

2cf710b8-11ab-4ee1-a212-9fbb2e315e38

Public Version Date

December 04, 2020

Public Version Number

5

DI Record Publish Date

April 18, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-