SONTEC EAR RASPATORY SET 475-615

GUDID 00192896042551

SONTEC EAR RASPATORY SET

SONTEC INSTRUMENTS, INC.

Middle ear file/rasp
Primary Device ID00192896042551
NIH Device Record Key9ff05cf0-cda9-44e4-b99e-2695ad759eda
Commercial Distribution StatusIn Commercial Distribution
Brand NameSONTEC EAR RASPATORY SET
Version Model Number475-615
Catalog Number475-615
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

Device Dimensions

Length7.25 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100192896042551 [Primary]

FDA Product Code

JYYRASP, EAR

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00192896042551]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-12-07
Device Publish Date2018-09-14

Devices Manufactured by SONTEC INSTRUMENTS, INC.

00192896121621 - Gelpi Retractor2025-06-25 Gelpi Retractor Deep Angle With Enclosed Ratchet 6.5 Inches
00192896121638 - Debakey Neonatal Clamp2025-06-25 Debakey Neonatal Clamp Medium Full Curved Jaw/Shank A
00192896121645 - Debakey Neonatal Clamp2025-06-25 Debakey Neonatal Clamp Double Angled 45 Degrees Jaw/Shank A
00192896121652 - Debakey Scissors2025-06-25 Debakey Scissors 45 Degree Angle Power Cut
00192896121362 - Barraquer Iris Spatula2025-06-16 Barraquer Iris Spatula Round Smooth Curved Blades
00192896121607 - Micasept Top Dur Needle Holder2025-06-16 Micasept Top Dur Needle Holder With Hegar Ratchet Curved 4.5 Millimeter Tip
00192896121614 - Circular Cutting Punch2025-06-16 Circular Cutting Punch 70 Degree Upturned With Flushing Connector
00192896121577 - Stefan Mini Bone Holding Forceps2025-06-02 Stefan Mini Bone Holding Forceps With Speed Lock Serrated Jaw Curved Delicate Quantum

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