ALGERBRUSH II CORNEAL RUST RING REMOVER BURR 11-4609

GUDID 00192896072398

ALGERBRUSH II CORNEAL RUST RING REMOVER BURR

SONTEC INSTRUMENTS, INC.

Corneal bur, rust ring removal, reusable
Primary Device ID00192896072398
NIH Device Record Keye50c8e53-f6cb-4789-a2cd-981a35554da6
Commercial Distribution StatusIn Commercial Distribution
Brand NameALGERBRUSH II CORNEAL RUST RING REMOVER BURR
Version Model Number11-4609
Catalog Number11-4609
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

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100192896072398 [Primary]

FDA Product Code

HOGBurr, Corneal, Battery-Powered
OHWBurr, Corneal, Battery Powered, Rust Ring Removal

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00192896072398]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896072398]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896072398]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896072398]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896072398]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896072398]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896072398]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896072398]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896072398]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896072398]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896072398]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896072398]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896072398]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896072398]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896072398]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896072398]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-05-14
Device Publish Date2018-09-19

Devices Manufactured by SONTEC INSTRUMENTS, INC.

00192896121379 - Wire Twister2025-04-21 Wire Twister Tungsten Carbide Serrated Blunt Jaw Quantum
00192896121386 - Winged Elevator Set2025-04-21 Winged Elevator Set Tungsten Carbide Dust Long Handle (#1,2,3,4,5) With Tray
00192896121393 - Dental Elevator Combo Set2025-04-21 Dental Elevator Combo Set Without Tray
00192896121409 - Dental Elevator Combo Set2025-04-21 Dental Elevator Combo Set With Tray
00192896121416 - Verbrugge Rogalski Bone Clamp2025-04-21 Verbrugge Rogalski Bone Clamp With Speed Lock 1.5 Millimeters Jaw Light Weight
00192896121423 - Freeman Kaye Scissors2025-04-21 Freeman Kaye Scissors Spread Handle Tungsten Carbide Power Cut One Serrated Blade Curved Short Tip
00192896121430 - Micro Finger and Spatula2025-04-21 Micro Finger and Spatula Double Ended Left Handed Titanium
00192896121447 - Winged Dental Elevator Set2025-04-21 Winged Dental Elevator Short Handle Complete Set With Tray

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.