Catalog Number

-

Brand Name

INTRAcel

Version/Model Number

INTRAcel

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K153727,K153727

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

f8f5c8d0-5399-44e6-bed6-271d9b91efbe

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 03, 2016

Package DI Number

8800020101037

Quantity per Package

1

Contains DI Package

08800020101013

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Wooden crate