STABILIZER TIPS - HEARTLINE STABILIZER TIPS - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: HEARTLINE STABILIZER TIPS

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

STABILIZER TIPS

Version/Model Number

2800-818

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 22, 2018

Issuing Agency

In HIBCC

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

-

Product Code Details

Product Code

MWS

Product Code Name

Stabilizer, Heart

Device Record Status

Public Device Record Key

7d660b11-5af8-40c4-809c-0809fc423cd7

Public Version Date

May 10, 2021

Public Version Number

8

DI Record Publish Date

August 19, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SONTEC INSTRUMENTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 10108
2 A medical device with a moderate to high risk that requires special controls. 3414