Empower Delivery System - Legacy Hand Piece 600um Fiber Hand Piece w/ - LITECURE LLC

Duns Number:858768943

Device Description: Legacy Hand Piece 600um Fiber Hand Piece w/ Finger Switch, Cool Gray

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More Product Details

Catalog Number

-

Brand Name

Empower Delivery System

Version/Model Number

PRD-000477-000-03-L

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

ILY

Product Code Name

Lamp, Infrared, Therapeutic Heating

Device Record Status

Public Device Record Key

da707640-2aca-4238-a094-ef0a252834db

Public Version Date

July 08, 2022

Public Version Number

1

DI Record Publish Date

June 30, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LITECURE LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 27