HEART STABILIZER FINGER ATTACHMENT - HEARTLINE HEART STABILIZER FINGER ATTACHMENT - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: HEARTLINE HEART STABILIZER FINGER ATTACHMENT 2L-TWO LONG FINGERS (401-211S)

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More Product Details

Catalog Number

-

Brand Name

HEART STABILIZER FINGER ATTACHMENT

Version/Model Number

2800-826

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

MWS

Product Code Name

Stabilizer, Heart

Device Record Status

Public Device Record Key

9aeb4af4-4cce-4b82-88d7-e204ae230001

Public Version Date

May 10, 2021

Public Version Number

3

DI Record Publish Date

September 07, 2018

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