Hu-Friedy - Magnetostrict.Generator 3000-25k,230V UK - HU-FRIEDY MFG. CO., LLC

Duns Number:005085972

Device Description: Magnetostrict.Generator 3000-25k,230V UK

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More Product Details

Catalog Number

UM3-25UK

Brand Name

Hu-Friedy

Version/Model Number

UM3-25UK

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 19, 2022

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

K100401

Product Code Details

Product Code

ELC

Product Code Name

Scaler, ultrasonic

Device Record Status

Public Device Record Key

9762d99f-7cff-4cb9-b5ea-2103aea13882

Public Version Date

January 20, 2022

Public Version Number

4

DI Record Publish Date

September 21, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HU-FRIEDY MFG. CO., LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 7436
2 A medical device with a moderate to high risk that requires special controls. 238