COOLEY AORTIC CLAMP

GUDID B09921001500

COOLEY AORTIC CLAMP CURVED JAW CURVED SHANK

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 IDB09921001500
NIH Device Record Keyaf2345ed-bbe6-470e-84a2-c0690d116eab
Commercial Distribution StatusIn Commercial Distribution
Brand NameCOOLEY AORTIC CLAMP
Version Model Number2100-150
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 Batchfalse
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

Phone8008217496
EmailINFO@SONTECINSTRUMENTS.COM
Phone8008217496
EmailINFO@SONTECINSTRUMENTS.COM
Phone8008217496
EmailINFO@SONTECINSTRUMENTS.COM

Device Dimensions

Length10.5 Inch
Length10.5 Inch
Length10.5 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100192896002029 [Primary]
HIBCCB09921001500 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXCClamp, Vascular

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B09921001500]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[B09921001500]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[B09921001500]

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 Date2018-08-22

On-Brand Devices [COOLEY AORTIC CLAMP ]

B09921001500COOLEY AORTIC CLAMP CURVED JAW CURVED SHANK
B09921001520COOLEY AORTIC CLAMP DOUBLE CURVED JAW CURVED SHANK
B09921001400COOLEY AORTIC CLAMP DOUBLE ANGLED JAW CURVED SHANK

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