TorqLoc Instrument OP-II-0815B

GUDID E302OPII0815B9

TorqLoc K-wire Ø0.8 mm, length 150 mm, blunt ends, for 4/5/6 mm interference screw

Bioretec Oy

Orthopaedic bone wire
Primary Device IDE302OPII0815B9
NIH Device Record Key7d25a775-de57-410b-b296-04e898407243
Commercial Distribution StatusIn Commercial Distribution
Brand NameTorqLoc Instrument
Version Model NumberOP-II-0815B
Catalog NumberOP-II-0815B
Company DUNS368715301
Company NameBioretec Oy
Device Count1
DM Exempttrue
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 Dimensions

Width0.8 Millimeter
Length150 Millimeter
Width0.8 Millimeter
Length150 Millimeter
Width0.8 Millimeter
Length150 Millimeter
Width0.8 Millimeter
Length150 Millimeter
Width0.8 Millimeter
Length150 Millimeter
Width0.8 Millimeter
Length150 Millimeter
Width0.8 Millimeter
Length150 Millimeter
Width0.8 Millimeter
Length150 Millimeter
Width0.8 Millimeter
Length150 Millimeter
Width0.8 Millimeter
Length150 Millimeter
Width0.8 Millimeter
Length150 Millimeter
Width0.8 Millimeter
Length150 Millimeter
Width0.8 Millimeter
Length150 Millimeter
Width0.8 Millimeter
Length150 Millimeter
Width0.8 Millimeter
Length150 Millimeter
Width0.8 Millimeter
Length150 Millimeter
Width0.8 Millimeter
Length150 Millimeter
Width0.8 Millimeter
Length150 Millimeter
Width0.8 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE302OPII0815B9 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[E302OPII0815B9]

Moist Heat or Steam Sterilization


[E302OPII0815B9]

Moist Heat or Steam Sterilization


[E302OPII0815B9]

Moist Heat or Steam Sterilization


[E302OPII0815B9]

Moist Heat or Steam Sterilization


[E302OPII0815B9]

Moist Heat or Steam Sterilization


[E302OPII0815B9]

Moist Heat or Steam Sterilization


[E302OPII0815B9]

Moist Heat or Steam Sterilization


[E302OPII0815B9]

Moist Heat or Steam Sterilization


[E302OPII0815B9]

Moist Heat or Steam Sterilization


[E302OPII0815B9]

Moist Heat or Steam Sterilization


[E302OPII0815B9]

Moist Heat or Steam Sterilization


[E302OPII0815B9]

Moist Heat or Steam Sterilization


[E302OPII0815B9]

Moist Heat or Steam Sterilization


[E302OPII0815B9]

Moist Heat or Steam Sterilization


[E302OPII0815B9]

Moist Heat or Steam Sterilization


[E302OPII0815B9]

Moist Heat or Steam Sterilization


[E302OPII0815B9]

Moist Heat or Steam Sterilization


[E302OPII0815B9]

Moist Heat or Steam Sterilization


[E302OPII0815B9]

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

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