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 ID: E302OPII80109
• NIH Device Record Key: ce40075b-40e5-4f3b-827d-fb8557bf804c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TorqLoc Instrument
• Version Model Number: OP-II-8010
• Catalog Number: OP-II-8010
• Company DUNS: 368715301
• Company Name: Bioretec Oy
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +358207789500
• Email: sales@bioretec.com
• Phone: +358207789500
• Email: sales@bioretec.com
• Phone: +358207789500
• Email: sales@bioretec.com
• Phone: +358207789500
• Email: sales@bioretec.com
• Phone: +358207789500
• Email: sales@bioretec.com
• Phone: +358207789500
• Email: sales@bioretec.com
• Phone: +358207789500
• Email: sales@bioretec.com
• Phone: +358207789500
• Email: sales@bioretec.com
• Phone: +358207789500
• Email: sales@bioretec.com
• Phone: +358207789500
• Email: sales@bioretec.com
• Phone: +358207789500
• Email: sales@bioretec.com
• Phone: +358207789500
• Email: sales@bioretec.com
• Phone: +358207789500
• Email: sales@bioretec.com
• Phone: +358207789500
• Email: sales@bioretec.com
• Phone: +358207789500
• Email: sales@bioretec.com
• Phone: +358207789500
• Email: sales@bioretec.com
• Phone: +358207789500
• Email: sales@bioretec.com
• Phone: +358207789500
• Email: sales@bioretec.com
• Phone: +358207789500
• Email: sales@bioretec.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E302OPII80109 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[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 Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-02-15

On-Brand Devices [TorqLoc Instrument]

• E302OPISC90139: TorqLoc Large handle, cannulated, quick coupling
• E302OPII90329: TorqLoc Torx shaft for 4/5/6 mm interference screw with quick coupling
• E302OPII90319: TorqLoc Torx driver for 7/8/9/10 mm interference screw
• E302OPII80109: TorqLoc Notcher for 7/8/9/10 mm interference screw
• E302OPII50009: TorqLoc Drill bit Ø5.0 mm, cannulated, for 5 mm interference screws, quick coupling
• E302OPII40009: TorqLoc Drill bit Ø4.0 mm, cannulated, for 4 mm interference screws, quick coupling
• E302OPII1630B9: TorqLoc K-wire Ø1.6 mm, length 300 mm, blunt ends, for 7/8/9/10 mm interference screw
• E302OPII1624B9: TorqLoc K-wire Ø1.6 mm, length 240 mm, blunt ends, for 7/8/9/10 mm interference screw
• E302OPII0830B9: TorqLoc K-wire Ø0.8 mm, length 300 mm, blunt ends, for 4/5/6 mm interference screw
• E302OPII0815B9: TorqLoc K-wire Ø0.8 mm, length 150 mm, blunt ends, for 4/5/6 mm interference screw