Catalog Number

TSMG-35-90-7-LES

Brand Name

Lunderquist

Version/Model Number

G49225

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

DQX

Product Code Name

WIRE, GUIDE, CATHETER

Public Device Record Key

281fdd30-c70a-4e72-b1d7-3e1b3abff0de

Public Version Date

September 28, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

10827002492254

Quantity per Package

5

Contains DI Package

00827002492257

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-