Hayden Medical - LED Light Source, comparable to most 300w Xenon, - Hayden Medical, Inc.

Duns Number:618214410

Device Description: LED Light Source, comparable to most 300w Xenon, with 4 port turret (ACMI, Wolf, Storz and LED Light Source, comparable to most 300w Xenon, with 4 port turret (ACMI, Wolf, Storz and Olympus) Color temperature:6500°K @ 75 CRI or 5600°K @ 92 CRI. Expected LED life of 30,000 hours

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More Product Details

Catalog Number

LS-300LED

Brand Name

Hayden Medical

Version/Model Number

LS-300LED

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

NTN

Product Code Name

Led light source

Device Record Status

Public Device Record Key

8ddf50c3-a12f-48fa-b67a-7bf9db79c03a

Public Version Date

August 11, 2022

Public Version Number

1

DI Record Publish Date

August 03, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HAYDEN MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2893
2 A medical device with a moderate to high risk that requires special controls. 195