Catalog Number

R-10002

Brand Name

Tricera™ Handpiece

Version/Model Number

R-10002

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 02, 2020

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K162770

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

910e9e20-45d4-4487-9dfc-f7638275a2b9

Public Version Date

July 04, 2022

Public Version Number

5

DI Record Publish Date

February 20, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-