UreTron Flex Hand Piece - UreTron Flex Hand piece for Flex and Semi Flex - MED-SONICS CORPORATION

Duns Number:009836084

Device Description: UreTron Flex Hand piece for Flex and Semi Flex Probes

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More Product Details

Catalog Number

-

Brand Name

UreTron Flex Hand Piece

Version/Model Number

URT-TF

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

K160198

Product Code Details

Product Code

FFK

Product Code Name

Lithotriptor, Electro-Hydraulic

Device Record Status

Public Device Record Key

a003b640-d23e-4374-81fd-5131e4d9375e

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 01, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MED-SONICS CORPORATION" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 30