TorqLoc Instrument OP-II-8010

GUDID E302OPII80109

TorqLoc Notcher for 7/8/9/10 mm interference screw

Bioretec Oy

Orthopaedic bone screw starter/notcher
Primary Device IDE302OPII80109
NIH Device Record Keyce40075b-40e5-4f3b-827d-fb8557bf804c
Commercial Distribution StatusIn Commercial Distribution
Brand NameTorqLoc Instrument
Version Model NumberOP-II-8010
Catalog NumberOP-II-8010
Company DUNS368715301
Company NameBioretec Oy
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+358207789500
Emailsales@bioretec.com
Phone+358207789500
Emailsales@bioretec.com
Phone+358207789500
Emailsales@bioretec.com
Phone+358207789500
Emailsales@bioretec.com
Phone+358207789500
Emailsales@bioretec.com
Phone+358207789500
Emailsales@bioretec.com
Phone+358207789500
Emailsales@bioretec.com
Phone+358207789500
Emailsales@bioretec.com
Phone+358207789500
Emailsales@bioretec.com
Phone+358207789500
Emailsales@bioretec.com
Phone+358207789500
Emailsales@bioretec.com
Phone+358207789500
Emailsales@bioretec.com
Phone+358207789500
Emailsales@bioretec.com
Phone+358207789500
Emailsales@bioretec.com
Phone+358207789500
Emailsales@bioretec.com
Phone+358207789500
Emailsales@bioretec.com
Phone+358207789500
Emailsales@bioretec.com
Phone+358207789500
Emailsales@bioretec.com
Phone+358207789500
Emailsales@bioretec.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE302OPII80109 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[E302OPII80109]

Moist Heat or Steam Sterilization


[E302OPII80109]

Moist Heat or Steam Sterilization


[E302OPII80109]

Moist Heat or Steam Sterilization


[E302OPII80109]

Moist Heat or Steam Sterilization


[E302OPII80109]

Moist Heat or Steam Sterilization


[E302OPII80109]

Moist Heat or Steam Sterilization


[E302OPII80109]

Moist Heat or Steam Sterilization


[E302OPII80109]

Moist Heat or Steam Sterilization


[E302OPII80109]

Moist Heat or Steam Sterilization


[E302OPII80109]

Moist Heat or Steam Sterilization


[E302OPII80109]

Moist Heat or Steam Sterilization


[E302OPII80109]

Moist Heat or Steam Sterilization


[E302OPII80109]

Moist Heat or Steam Sterilization


[E302OPII80109]

Moist Heat or Steam Sterilization


[E302OPII80109]

Moist Heat or Steam Sterilization


[E302OPII80109]

Moist Heat or Steam Sterilization


[E302OPII80109]

Moist Heat or Steam Sterilization


[E302OPII80109]

Moist Heat or Steam Sterilization


[E302OPII80109]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-02-15

On-Brand Devices [TorqLoc Instrument]

E302OPISC90139TorqLoc Large handle, cannulated, quick coupling
E302OPII90329TorqLoc Torx shaft for 4/5/6 mm interference screw with quick coupling
E302OPII90319TorqLoc Torx driver for 7/8/9/10 mm interference screw
E302OPII80109TorqLoc Notcher for 7/8/9/10 mm interference screw
E302OPII50009TorqLoc Drill bit Ø5.0 mm, cannulated, for 5 mm interference screws, quick coupling
E302OPII40009TorqLoc Drill bit Ø4.0 mm, cannulated, for 4 mm interference screws, quick coupling
E302OPII1630B9TorqLoc K-wire Ø1.6 mm, length 300 mm, blunt ends, for 7/8/9/10 mm interference screw
E302OPII1624B9TorqLoc K-wire Ø1.6 mm, length 240 mm, blunt ends, for 7/8/9/10 mm interference screw
E302OPII0830B9TorqLoc K-wire Ø0.8 mm, length 300 mm, blunt ends, for 4/5/6 mm interference screw
E302OPII0815B9TorqLoc K-wire Ø0.8 mm, length 150 mm, blunt ends, for 4/5/6 mm interference screw

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