MYOCARDIAL DILATOR

GUDID B09927002500

MYOCARDIAL DILATOR GRADUATED

SONTEC INSTRUMENTS, INC.

Vascular dilator, reusable Vascular dilator, reusable Vascular dilator, reusable
Primary Device IDB09927002500
NIH Device Record Key06d2cbda-6ee8-4a5c-bb14-760c8d35bcaf
Commercial Distribution StatusIn Commercial Distribution
Brand NameMYOCARDIAL DILATOR
Version Model Number2700-250
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

Length6 Inch
Length6 Inch
Length6 Inch
Length6 Inch
Length6 Inch
Length6 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100192896005938 [Primary]
HIBCCB09927002500 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DWPDilator, Vessel, Surgical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B09927002500]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[B09927002500]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[B09927002500]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-09-21
Device Publish Date2018-08-21

On-Brand Devices [MYOCARDIAL DILATOR ]

B09927002500MYOCARDIAL DILATOR GRADUATED
B09927002520MYOCARDIAL DILATOR GRADUATED

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