Catalog Number

XL-HD

Brand Name

NA

Version/Model Number

XL-HD

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

K080802

Product Code

GEY

Product Code Name

MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Public Device Record Key

6169201f-5e05-49db-afb3-126a1c0015c0

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 05, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-