Catalog Number

8403

Brand Name

EXPRO ELITE

Version/Model Number

IPN913619

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

MMX

Product Code Name

Device, percutaneous retrieval

Public Device Record Key

6fb7a01e-fe61-496f-8533-46f5e6a01875

Public Version Date

July 08, 2021

Public Version Number

4

DI Record Publish Date

January 22, 2019

Package DI Number

30841156101569

Quantity per Package

1

Contains DI Package

10841156101565

Package Discontinue Date

June 19, 2019

Package Status

Not in Commercial Distribution

Package Type

Box