Catalog Number

-

Brand Name

Reprocessed Celon ProSleep Plus RFITT, 1.3mm, 0-25W, 2 Pins.

Version/Model Number

WB990311

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

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

K052692

Product Code

NUJ

Product Code Name

Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed

Public Device Record Key

e91fe281-31b4-44a7-86e8-09d734ce6257

Public Version Date

August 20, 2021

Public Version Number

1

DI Record Publish Date

August 12, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-