DEBAKEY AORTIC ANEURYSM CLAMP

GUDID B09921007600

DEBAKEY AORTIC ANEURYSM CLAMP CURVED

SONTEC INSTRUMENTS, INC.

Surgical soft-tissue manipulation forceps, scissors-like, reusable Surgical soft-tissue manipulation forceps, scissors-like, reusable Surgical soft-tissue manipulation forceps, scissors-like, reusable
Primary Device IDB09921007600
NIH Device Record Keyd3bce977-02d5-407e-9d19-4e8a984c70c6
Commercial Distribution StatusIn Commercial Distribution
Brand NameDEBAKEY AORTIC ANEURYSM CLAMP
Version Model Number2100-760
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

Length10.75 Inch
Length10.75 Inch
Length10.75 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100192896003293 [Primary]
HIBCCB09921007600 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXCClamp, Vascular

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B09921007600]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[B09921007600]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[B09921007600]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-08-21
Device Publish Date2018-08-28

On-Brand Devices [DEBAKEY AORTIC ANEURYSM CLAMP]

B09921007640DEBAKEY AORTIC ANEURYSM CLAMP CURVED
B09921007620DEBAKEY AORTIC ANEURYSM CLAMP CURVED
B09921007600DEBAKEY AORTIC ANEURYSM CLAMP CURVED
B09921006980DEBAKEY AORTIC ANEURYSM CLAMP CURVED HEAVY JAW
B09921006960DEBAKEY AORTIC ANEURYSM CLAMP CURVED JAW REVERSE CURVED SHANK
B09921006940DEBAKEY AORTIC ANEURYSM CLAMP CURVED JAW REVERSE CURVED SHANK
B09921006920DEBAKEY AORTIC ANEURYSM CLAMP CURVED JAW REVERSE CURVED SHANK
B09921006900DEBAKEY AORTIC ANEURYSM CLAMP CURVED JAW REVERSE CURVED SHANK

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.