Catalog Number

KL 703 LED

Brand Name

INTRAmatic KL 703 LED

Version/Model Number

1.007.0150

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K103027

Product Code

EKX

Product Code Name

HANDPIECE, DIRECT DRIVE, AC-POWERED

Public Device Record Key

2f4fc55b-4fd2-4ade-8ffb-85c8e5068e2a

Public Version Date

August 25, 2022

Public Version Number

6

DI Record Publish Date

September 26, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-