BALFOUR RETRACTOR 1100-609

GUDID 00192896097773

BALFOUR RETRACTOR DOUBLE BAR WITH DETACHABLE WIRE BLADES

SONTEC INSTRUMENTS, INC.

Self-retaining surgical retractor, reusable
Primary Device ID00192896097773
NIH Device Record Keyb6b9d4b0-004c-431a-af74-9da92737ce7b
Commercial Distribution StatusIn Commercial Distribution
Brand NameBALFOUR RETRACTOR
Version Model Number1100-609
Catalog Number1100-609
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 Latextrue
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
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com

Device Dimensions

Length14 Inch
Length14 Inch
Length14 Inch
Length14 Inch
Length14 Inch
Length14 Inch
Length14 Inch
Length14 Inch
Length14 Inch
Length14 Inch
Length14 Inch
Length14 Inch
Length14 Inch
Length14 Inch
Length14 Inch
Length14 Inch
Length14 Inch
Length14 Inch
Length14 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100192896097773 [Primary]

FDA Product Code

FFORetractor, Self-Retaining

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00192896097773]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896097773]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896097773]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896097773]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896097773]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896097773]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896097773]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896097773]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896097773]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896097773]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896097773]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896097773]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896097773]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896097773]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896097773]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896097773]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896097773]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896097773]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896097773]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-07-09
Device Publish Date2019-06-18

On-Brand Devices [BALFOUR RETRACTOR]

00192896081819BALFOUR RETRACTOR LARGE SPREAD
00192896072077BALFOUR RETRACTOR DOUBLE BAR FENESTRATED SIDE BLADE
00192896072060BALFOUR RETRACTOR DOUBLE BAR FENESTRATED SIDE BLADE
00192896072053BALFOUR RETRACTOR DOUBLE BAR
00192896072046BALFOUR RETRACTOR
00192896071988BALFOUR RETRACTOR WITH DOUBLE BAR DETACHABLE WIRE BLADES
00192896071964BALFOUR RETRACTOR LARGE SIZE
00192896071957BALFOUR RETRACTOR WITH DOUBLE BAR
00192896071940BALFOUR RETRACTOR WITH DOUBLE BAR FENESTRATE SIDE BLADES
00192896097759BALFOUR RETRACTOR WITH DOUBLE BAR FENESTRATED SIDE BLADES
00192896097773BALFOUR RETRACTOR DOUBLE BAR WITH DETACHABLE WIRE BLADES
00192896097766BALFOUR RETRACTOR DOUBLE BAR SPREAD
00192896094918BALFOUR RETRACTOR DOUBLE BAR WITH BLADES
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