HEARTLINE DEBAKEY GRASPER - HEARTLINE DEBAKEY GRASPER 1X2 JAW STRAIGHT - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: HEARTLINE DEBAKEY GRASPER 1X2 JAW STRAIGHT

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More Product Details

Catalog Number

-

Brand Name

HEARTLINE DEBAKEY GRASPER

Version/Model Number

2800-7827

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K152400

Product Code Details

Product Code

GCJ

Product Code Name

Laparoscope, General & Plastic Surgery

Device Record Status

Public Device Record Key

ef1d3d6d-4e5c-41e8-89b9-c57320c442b6

Public Version Date

September 24, 2018

Public Version Number

6

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