Catalog Number

OS-RMH-B

Brand Name

Reusable Monpolar Handle

Version/Model Number

OS-RMH-B

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

GCJ

Product Code Name

Laparoscope, General & Plastic Surgery

Public Device Record Key

505f7b59-9790-4acc-b150-3e6c0b9e4ede

Public Version Date

August 17, 2021

Public Version Number

4

DI Record Publish Date

November 14, 2016

Package DI Number

B354OSRMHB10

Quantity per Package

10

Contains DI Package

B354OSRMHB0

Package Discontinue Date

November 14, 2019

Package Status

Not in Commercial Distribution

Package Type

-