CSU BABY BALFOUR RETRACTOR 1100-611C

GUDID 00192896048454

CSU PEDIATRIC BALFOUR RETRACTOR DOUBLE BAR FENESTRATED SIDE BLADES

SONTEC INSTRUMENTS, INC.

Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Rigid endoscopic tissue manipulation forceps, reusable Rigid endoscopic tissue manipulation forceps, reusable Rigid endoscopic tissue manipulation forceps, reusable Rigid endoscopic tissue manipulation forceps, reusable Rigid endoscopic tissue manipulation forceps, reusable Rigid endoscopic tissue manipulation forceps, reusable Rigid endoscopic tissue manipulation forceps, reusable Rigid endoscopic tissue manipulation forceps, reusable Rigid endoscopic tissue manipulation forceps, reusable Rigid endoscopic tissue manipulation forceps, reusable Rigid endoscopic tissue manipulation forceps, reusable Rigid endoscopic tissue manipulation forceps, reusable Rigid endoscopic tissue manipulation forceps, reusable Rigid endoscopic tissue manipulation forceps, reusable Rigid endoscopic tissue manipulation forceps, reusable Rigid endoscopic tissue manipulation forceps, reusable Rigid endoscopic tissue manipulation forceps, reusable
Primary Device ID00192896048454
NIH Device Record Key8dc7f057-2292-4149-9a95-e5e42efc8a82
Commercial Distribution StatusIn Commercial Distribution
Brand NameCSU BABY BALFOUR RETRACTOR
Version Model Number1100-611C
Catalog Number1100-611C
Company DUNS040729840
Company NameSONTEC INSTRUMENTS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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

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
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
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

Length7 Inch
Length7 Inch
Length7 Inch
Length7 Inch
Length7 Inch
Length7 Inch
Length7 Inch
Length7 Inch
Length7 Inch
Length7 Inch
Length7 Inch
Length7 Inch
Length7 Inch
Length7 Inch
Length7 Inch
Length7 Inch
Length7 Inch
Length7 Inch
Length7 Inch
Length22.7 Centimeter
Device Size Text, specify0
Length22.7 Centimeter
Device Size Text, specify0
Length22.7 Centimeter
Device Size Text, specify0
Length22.7 Centimeter
Device Size Text, specify0
Length22.7 Centimeter
Device Size Text, specify0
Length22.7 Centimeter
Device Size Text, specify0
Length22.7 Centimeter
Device Size Text, specify0
Length22.7 Centimeter
Device Size Text, specify0
Length22.7 Centimeter
Device Size Text, specify0
Length22.7 Centimeter
Device Size Text, specify0
Length22.7 Centimeter
Device Size Text, specify0
Length22.7 Centimeter
Device Size Text, specify0
Length22.7 Centimeter
Device Size Text, specify0
Length22.7 Centimeter
Device Size Text, specify0
Length22.7 Centimeter
Device Size Text, specify0
Length22.7 Centimeter
Device Size Text, specify0
Length22.7 Centimeter
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100192896048454 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FFORETRACTOR, SELF-RETAINING
GCJLaparoscope, General & Plastic Surgery

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00192896048454]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896048454]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896048454]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896048454]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896048454]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896048454]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896048454]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896048454]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896048454]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896048454]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896048454]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896048454]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896048454]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896048454]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896048454]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896048454]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896048454]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896048454]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896048454]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896048454]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896048454]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896048454]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896048454]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896048454]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896048454]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896048454]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896048454]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896048454]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896048454]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896048454]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896048454]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896048454]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896048454]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896048454]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896048454]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896048454]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-15
Device Publish Date2018-09-14

On-Brand Devices [CSU BABY BALFOUR RETRACTOR]

00192896048454CSU PEDIATRIC BALFOUR RETRACTOR DOUBLE BAR FENESTRATED SIDE BLADES
00192896048447CSU PEDIATRIC BALFOUR RETRACTOR DOUBLE BAR
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