Catalog Number

-

Brand Name

NA

Version/Model Number

2067L

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 26, 2018

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

P890003

Product Code

KRG

Product Code Name

Programmer, pacemaker

Public Device Record Key

80eb9b6a-3afa-4ada-9a5a-47f6ad72606c

Public Version Date

July 30, 2018

Public Version Number

4

DI Record Publish Date

September 23, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-