Catalog Number

-

Brand Name

Revolver Universal Connector

Version/Model Number

RLP-A

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

K140362

Product Code

MPA

Product Code Name

Endoilluminator

Public Device Record Key

6eb30b8d-c4bd-40b4-b02d-bad6ca7be5a4

Public Version Date

June 16, 2020

Public Version Number

1

DI Record Publish Date

June 08, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-