Catalog Number

GE803SU

Brand Name

HI-LINE XXS

Version/Model Number

GE803SU

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

Yes

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

GEY

Product Code Name

MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Public Device Record Key

f863db30-7d7d-47e8-94d6-d32a328be53a

Public Version Date

May 04, 2020

Public Version Number

1

DI Record Publish Date

April 24, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-