Catalog Number

401764

Brand Name

Pacel™

Version/Model Number

401764

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)

Yes

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

-

Product Code

LDF

Product Code Name

ELECTRODE, PACEMAKER, TEMPORARY

Public Device Record Key

a2a2a69c-237c-4917-8bf8-c7a50c4f8760

Public Version Date

September 21, 2020

Public Version Number

4

DI Record Publish Date

January 28, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-