Catalog Number

8785

Brand Name

EMPOWER™

Version/Model Number

00884450269190

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

MMX

Product Code Name

Device, percutaneous retrieval

Public Device Record Key

c66d4b91-b5d8-485e-b2c2-645d093e99c5

Public Version Date

July 08, 2021

Public Version Number

5

DI Record Publish Date

December 18, 2017

Package DI Number

10884450269197

Quantity per Package

20

Contains DI Package

00884450269190

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-