Catalog Number

2863

Brand Name

N/A

Version/Model Number

2863

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 08, 2017

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

HWE

Product Code Name

INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Public Device Record Key

4ddc1921-d824-42a0-a109-1f6c3826cd46

Public Version Date

January 22, 2021

Public Version Number

4

DI Record Publish Date

April 12, 2016

Package DI Number

23596010464747

Quantity per Package

2

Contains DI Package

03596010464743

Package Discontinue Date

August 08, 2017

Package Status

Not in Commercial Distribution

Package Type

BX