Catalog Number

401768

Brand Name

Pacel™

Version/Model Number

401768

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)

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

00b319d4-0ed4-49cd-807d-511d32542929

Public Version Date

September 21, 2020

Public Version Number

4

DI Record Publish Date

July 31, 2015

Package DI Number

15414734001097

Quantity per Package

5

Contains DI Package

05414734001090

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-