SYSTEM TWO LED - SYSTEM TWO D3, DUAL, IL-CR SURGICAL LIGHT - Medical Illumination International Inc.

Duns Number:093357739

Device Description: SYSTEM TWO D3, DUAL, IL-CR SURGICAL LIGHT

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More Product Details

Catalog Number

-

Brand Name

SYSTEM TWO LED

Version/Model Number

SD3CD3-CNS-LCH

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K100388,K100388

Product Code Details

Product Code

FST

Product Code Name

Light, Surgical, Fiberoptic

Device Record Status

Public Device Record Key

59a7e787-6b5f-4563-9d6a-8a85e5b10993

Public Version Date

September 19, 2022

Public Version Number

2

DI Record Publish Date

March 16, 2020

Additional Identifiers

Package DI Number

01816835023201

Quantity per Package

1

Contains DI Package

00816835023202

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX

"MEDICAL ILLUMINATION INTERNATIONAL INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 112
2 A medical device with a moderate to high risk that requires special controls. 58