CARDIOPLEGIA NEEDLE

GUDID B099280074930

HEARTLINE CARDIOPLEGIA NEEDLE

SONTEC INSTRUMENTS, INC.

Pericardiocentesis needle, reusable Pericardiocentesis needle, reusable Pericardiocentesis needle, reusable
Primary Device IDB099280074930
NIH Device Record Key47b95d56-aae5-46bb-a98b-2be04bf55a7c
Commercial Distribution StatusIn Commercial Distribution
Brand NameCARDIOPLEGIA NEEDLE
Version Model Number2800-7493
Company DUNS040729840
Company NameSONTEC INSTRUMENTS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Perscriptionfalse
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

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100192896070226 [Primary]
HIBCCB099280074930 [Previous]

FDA Product Code

GDMNeedle, Aspiration And Injection, Reusable

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B099280074930]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[B099280074930]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[B099280074930]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-08
Device Publish Date2018-09-06

On-Brand Devices [CARDIOPLEGIA NEEDLE]

B099280074930HEARTLINE CARDIOPLEGIA NEEDLE
B099280074900HEARTLINE CARDIOPLEGIA NEEDLE

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