Catalog Number

ELL-IN 02 01-N

Brand Name

ROMEO 2 INSTRUMENTATION

Version/Model Number

ELL-IN 02 01-N

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

HWJ

Product Code Name

Awl

Public Device Record Key

5d7613fb-359a-47d0-97bc-9c2a9f39af04

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

December 21, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-