STRONG AORTIC CLAMP

GUDID B09921007330

STRONG AORTIC DEBAKEY CLAMP

SONTEC INSTRUMENTS, INC.

Surgical soft-tissue manipulation forceps, scissors-like, reusable
Primary Device IDB09921007330
NIH Device Record Keyeaa5ec58-57c6-40a6-9893-b340de840f65
Commercial Distribution StatusIn Commercial Distribution
Brand NameSTRONG AORTIC CLAMP
Version Model Number2100-733
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

Length7.5 Inch
Length7.5 Inch
Length7.5 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100192896010475 [Primary]
HIBCCB09921007330 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXCClamp, Vascular

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B09921007330]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[B09921007330]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[B09921007330]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-08-21
Device Publish Date2018-08-24

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