Catalog Number

210449

Brand Name

NA

Version/Model Number

210449

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

HWE

Product Code Name

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

Public Device Record Key

530dbb5d-6024-459d-a668-52ebf9fd034d

Public Version Date

February 14, 2022

Public Version Number

4

DI Record Publish Date

August 29, 2015

Package DI Number

23596010102663

Quantity per Package

6

Contains DI Package

03596010102669

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX