Catalog Number

-

Brand Name

INTRAcel Tip

Version/Model Number

1011

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K153727,K153727,K153727

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

0b0274f6-cd83-4204-ba3a-83d49776098b

Public Version Date

February 26, 2020

Public Version Number

4

DI Record Publish Date

October 03, 2016

Package DI Number

28800020101024

Quantity per Package

5

Contains DI Package

18800020101027

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box