Catalog Number

110-003

Brand Name

ELCA™

Version/Model Number

110-003AA

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

P910001

Product Code

LPC

Product Code Name

Device, Angioplasty, Laser, Coronary

Public Device Record Key

12da5198-084d-41bc-b20f-88c6fca3985d

Public Version Date

October 26, 2021

Public Version Number

4

DI Record Publish Date

February 06, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-