Catalog Number

5513

Brand Name

Paradigm™

Version/Model Number

5513

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

-

Product Code

ELW

Product Code Name

MATERIAL, IMPRESSION

Public Device Record Key

d20fe11f-f9e3-448c-8301-6c40aa803384

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

July 24, 2017

Package DI Number

50605861009152

Quantity per Package

10

Contains DI Package

30605861009158

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX