LEXER GOUGE 330-035

GUDID 00192896077980

LEXER GOUGE

SONTEC INSTRUMENTS, INC.

Surgical gouge
Primary Device ID00192896077980
NIH Device Record Key7bbd92ef-8e70-4688-9a4b-bb9bae70027a
Commercial Distribution StatusIn Commercial Distribution
Brand NameLEXER GOUGE
Version Model Number330-035
Catalog Number330-035
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

Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100192896077980 [Primary]

FDA Product Code

GDHGOUGE, SURGICAL, GENERAL & PLASTIC SURGERY

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00192896077980]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-22
Device Publish Date2018-09-20

On-Brand Devices [LEXER GOUGE]

00192896077980LEXER GOUGE
00192896108516Lexer Gouge Phenolic Handle 25 Millimeters

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.