Catalog Number

-

Brand Name

Remington

Version/Model Number

SP2000HR

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K133201,K133201

Product Code

ONF

Product Code Name

Powered Light Based Non-Laser Surgical Instrument With Thermal Effect

Public Device Record Key

e2d13881-4f75-4a92-b967-c4e7b4e790c0

Public Version Date

October 19, 2021

Public Version Number

2

DI Record Publish Date

September 25, 2019

Package DI Number

10074590542926

Quantity per Package

4

Contains DI Package

00074590542929

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

cardboard