COOLEY SMALL RETRACTOR BLADE

GUDID B0994168640

COOLEY STYLE RETRACTOR BLADE

SONTEC INSTRUMENTS, INC.

Surgical retractor/retraction system blade, reusable
Primary Device IDB0994168640
NIH Device Record Key52cefff7-7328-47f0-bba7-2de04e28090b
Commercial Distribution Discontinuation2018-06-22
Commercial Distribution StatusNot in Commercial Distribution
Brand NameCOOLEY SMALL RETRACTOR BLADE
Version Model Number416-864
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
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com

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Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB0994168640 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCJLaparoscope, General & Plastic Surgery

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B0994168640]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[B0994168640]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[B0994168640]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[B0994168640]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[B0994168640]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[B0994168640]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[B0994168640]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[B0994168640]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[B0994168640]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[B0994168640]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[B0994168640]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[B0994168640]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[B0994168640]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[B0994168640]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[B0994168640]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[B0994168640]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[B0994168640]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number7
Public Version Date2019-03-11
Device Publish Date2016-08-26

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