Catalog Number

080995

Brand Name

miniRUMEL™ DEVICE

Version/Model Number

080995

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

DWS

Product Code Name

INSTRUMENTS, SURGICAL, CARDIOVASCULAR

Public Device Record Key

1b776ce5-c108-4ccc-b6ab-4ee82861e6df

Public Version Date

October 29, 2021

Public Version Number

2

DI Record Publish Date

October 09, 2020

Package DI Number

10850200006985

Quantity per Package

12

Contains DI Package

00850200006988

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner pack