MIS Inner Ear Suction Round Knife 412-934

GUDID 00192896121782

MIS Inner Ear Suction Round Knife 45 Degree 2.5 Millimeter 6.2 Millimeter

SONTEC INSTRUMENTS, INC.

Tympanotomy knife, reusable
Primary Device ID00192896121782
NIH Device Record Keya5886afc-cfa0-48ad-b48c-c7fd1329c8e3
Commercial Distribution StatusIn Commercial Distribution
Brand NameMIS Inner Ear Suction Round Knife
Version Model Number412-934
Catalog Number412-934
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

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

Length130 Millimeter
Length130 Millimeter
Length130 Millimeter
Length130 Millimeter
Length130 Millimeter
Length130 Millimeter
Length130 Millimeter
Length130 Millimeter
Length130 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100192896121782 [Primary]

FDA Product Code

LRCINSTRUMENT, ENT MANUAL SURGICAL

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00192896121782]

Dry Heat Sterilization


[00192896121782]

Dry Heat Sterilization


[00192896121782]

Dry Heat Sterilization


[00192896121782]

Dry Heat Sterilization


[00192896121782]

Dry Heat Sterilization


[00192896121782]

Dry Heat Sterilization


[00192896121782]

Dry Heat Sterilization


[00192896121782]

Dry Heat Sterilization


[00192896121782]

Dry Heat Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-25
Device Publish Date2025-07-17

On-Brand Devices [MIS Inner Ear Suction Round Knife]

00192896121799MIS Inner Ear Suction Round Knife 45 Degree 2.0 Millimeter 6.2 Millimeter
00192896121782MIS Inner Ear Suction Round Knife 45 Degree 2.5 Millimeter 6.2 Millimeter

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