SARNS MYOCARDIAL DILATOR

GUDID B09927002600

SARNS MYOCARDIAL DILATOR

SONTEC INSTRUMENTS, INC.

Vascular dilator, reusable Vascular dilator, reusable Vascular dilator, reusable
Primary Device IDB09927002600
NIH Device Record Keyec3cf69b-c776-4a89-8879-02de2c8cc39d
Commercial Distribution StatusIn Commercial Distribution
Brand NameSARNS MYOCARDIAL DILATOR
Version Model Number2700-260
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

Length8 Inch
Length8 Inch
Length8 Inch
Length8 Inch
Length8 Inch
Length8 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100192896005945 [Primary]
HIBCCB09927002600 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DWPDilator, Vessel, Surgical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B09927002600]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[B09927002600]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[B09927002600]

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 [SARNS MYOCARDIAL DILATOR]

B09927002660SARNS MYOCARDIAL DILATOR
B09927002640SARNS MYOCARDIAL DILATOR
B09927002620SARNS MYOCARDIAL DILATOR
B09927002600SARNS MYOCARDIAL DILATOR

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