Mitchell Aortic Valve Dilator

GUDID 00192896104785

Mitchell Aortic Valve Dilator

SONTEC INSTRUMENTS, INC.

Vascular dilator, reusable Vascular dilator, reusable Vascular dilator, reusable Vascular dilator, reusable Vascular dilator, reusable Vascular dilator, reusable Vascular dilator, reusable Vascular dilator, reusable Vascular dilator, reusable Vascular dilator, reusable Vascular dilator, reusable Vascular dilator, reusable Vascular dilator, reusable Vascular dilator, reusable
Primary Device ID00192896104785
NIH Device Record Key2d040136-1da6-481b-b80a-4ded17f1f25b
Commercial Distribution StatusIn Commercial Distribution
Brand NameMitchell Aortic Valve Dilator
Version Model Number2700-215
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)821-7496
Emailinfo@sontecinstruments.com
Phone+1(800)821-7496
Emailinfo@sontecinstruments.com
Phone+1(800)821-7496
Emailinfo@sontecinstruments.com
Phone+1(800)821-7496
Emailinfo@sontecinstruments.com
Phone+1(800)821-7496
Emailinfo@sontecinstruments.com
Phone+1(800)821-7496
Emailinfo@sontecinstruments.com
Phone+1(800)821-7496
Emailinfo@sontecinstruments.com
Phone+1(800)821-7496
Emailinfo@sontecinstruments.com
Phone+1(800)821-7496
Emailinfo@sontecinstruments.com
Phone+1(800)821-7496
Emailinfo@sontecinstruments.com
Phone+1(800)821-7496
Emailinfo@sontecinstruments.com
Phone+1(800)821-7496
Emailinfo@sontecinstruments.com
Phone+1(800)821-7496
Emailinfo@sontecinstruments.com
Phone+1(800)821-7496
Emailinfo@sontecinstruments.com

Device Dimensions

Device Size Text, specify0
Length9 Inch
Device Size Text, specify0
Length9 Inch
Device Size Text, specify0
Length9 Inch
Device Size Text, specify0
Length9 Inch
Device Size Text, specify0
Length9 Inch
Device Size Text, specify0
Length9 Inch
Device Size Text, specify0
Length9 Inch
Device Size Text, specify0
Length9 Inch
Device Size Text, specify0
Length9 Inch
Device Size Text, specify0
Length9 Inch
Device Size Text, specify0
Length9 Inch
Device Size Text, specify0
Length9 Inch
Device Size Text, specify0
Length9 Inch
Device Size Text, specify0
Length9 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100192896104785 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DWPDILATOR, VESSEL, SURGICAL

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00192896104785]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896104785]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896104785]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896104785]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896104785]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896104785]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896104785]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896104785]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896104785]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896104785]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896104785]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896104785]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896104785]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896104785]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-24
Device Publish Date2020-09-16

On-Brand Devices [Mitchell Aortic Valve Dilator]

B09927002300MITCHELL AORTIC VALVE DILATOR SET OF 24
B09927002250MITCHELL AORTIC VALVE DILATOR
B09927002240MITCHELL AORTIC VALVE DILATOR
B09927002230MITCHELL AORTIC VALVE DILATOR
B09927002220MITCHELL AORTIC VALVE DILATOR
B09927002210MITCHELL AORTIC VALVE DILATOR
B09927002200MITCHELL AORTIC VALVE DILATOR
B09927002190MITCHELL AORTIC VALVE DILATOR
B09927002180MITCHELL AORTIC VALVE DILATOR
B09927002170MITCHELL AORTIC VALVE DILATOR
B09927002160MITCHELL AORTIC VALVE DILATOR
B09927002150MITCHELL AORTIC VALVE DILATOR
B09927002140MITCHELL AORTIC VALVE DILATOR
B09927002130MITCHELL AORTIC VALVE DILATOR
B09927002120MITCHELL AORTIC VALVE DILATOR
B09927002110MITCHELL AORTIC VALVE DILATOR
B09927002100MITCHELL AORTIC VALVE DILATOR
B09927002090MITCHELL AORTIC VALVE DILATOR
B09927002080MITCHELL AORTIC VALVE DILATOR
B09927002070MITCHELL AORTIC VALVE DILATOR
B09927002060MITCHELL AORTIC VALVE DILATOR
B09927002050MITCHELL AORTIC VALVE DILATOR
B09927002040MITCHELL AORTIC VALVE DILATOR
B09927002030MITCHELL AORTIC VALVE DILATOR
B09927002020MITCHELL AORTIC VALVE DILATOR
00192896104785Mitchell Aortic Valve Dilator
00192896104778Mitchell Aortic Valve Dilator
00192896104761Mitchell Aortic Valve Dilator
00192896104754Mitchell Aortic Valve Dilator
00192896104747Mitchell Aortic Valve Dilator
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