MICTEC VESSEL SPATULA

GUDID B09920942160

MICTEC VESSEL SPATULA

SONTEC INSTRUMENTS, INC.

Vascular spatula
Primary Device IDB09920942160
NIH Device Record Key10dd3b15-aeb7-45a0-b945-62376daac3c9
Commercial Distribution StatusIn Commercial Distribution
Brand NameMICTEC VESSEL SPATULA
Version Model Number20942-16
Company DUNS040729840
Company NameSONTEC INSTRUMENTS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com

Device Dimensions

Length300 Millimeter
Length300 Millimeter
Length300 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100192896008786 [Primary]
HIBCCB09920942160 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCJLaparoscope, General & Plastic Surgery

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B09920942160]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[B09920942160]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[B09920942160]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-09-24
Device Publish Date2018-08-24

Devices Manufactured by SONTEC INSTRUMENTS, INC.

00192896119352 - Heartline MIS Bulldog Aortic Clamp Holder2024-09-12 Heartline MIS Bulldog Aortic Clamp Holder
00192896119369 - Heartline MIS Bulldog Aortic Clamp Screwer2024-09-12 Heartline MIS Bulldog Aortic Clamp Screwer
00192896119376 - Heartline MIS Bulldog Aortic Clamp2024-09-12 Heartline MIS Bulldog Aortic Clamp Straight
00192896119383 - Heartline MIS Bulldog Aortic Clamp2024-09-12 Heartline MIS Bulldog Aortic Clamp Straight
00192896119390 - Heartline MIS Bulldog Aortic Clamp2024-09-12 Heartline MIS Bulldog Aortic Clamp Straight
00192896119406 - Heartline MIS Bulldog Aortic Clamp2024-09-12 Heartline MIS Bulldog Aortic Clamp Curved
00192896119413 - Heartline MIS Bulldog Aortic Clamp2024-09-12 Heartline MIS Bulldog Aortic Clamp Curved
00192896119420 - Heartline MIS Bulldog Aortic Clamp2024-09-12 Heartline MIS Bulldog Aortic Clamp Curved

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.