| Primary Device ID | E302OPII0815B9 |
| NIH Device Record Key | 7d25a775-de57-410b-b296-04e898407243 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TorqLoc Instrument |
| Version Model Number | OP-II-0815B |
| Catalog Number | OP-II-0815B |
| Company DUNS | 368715301 |
| Company Name | Bioretec Oy |
| Device Count | 1 |
| DM Exempt | true |
| 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 |
| Phone | +358207789500 |
| sales@bioretec.com | |
| Phone | +358207789500 |
| sales@bioretec.com | |
| Phone | +358207789500 |
| sales@bioretec.com | |
| Phone | +358207789500 |
| sales@bioretec.com | |
| Phone | +358207789500 |
| sales@bioretec.com | |
| Phone | +358207789500 |
| sales@bioretec.com | |
| Phone | +358207789500 |
| sales@bioretec.com | |
| Phone | +358207789500 |
| sales@bioretec.com | |
| Phone | +358207789500 |
| sales@bioretec.com | |
| Phone | +358207789500 |
| sales@bioretec.com | |
| Phone | +358207789500 |
| sales@bioretec.com | |
| Phone | +358207789500 |
| sales@bioretec.com | |
| Phone | +358207789500 |
| sales@bioretec.com | |
| Phone | +358207789500 |
| sales@bioretec.com | |
| Phone | +358207789500 |
| sales@bioretec.com | |
| Phone | +358207789500 |
| sales@bioretec.com | |
| Phone | +358207789500 |
| sales@bioretec.com | |
| Phone | +358207789500 |
| sales@bioretec.com | |
| Phone | +358207789500 |
| sales@bioretec.com |
| Width | 0.8 Millimeter |
| Length | 150 Millimeter |
| Width | 0.8 Millimeter |
| Length | 150 Millimeter |
| Width | 0.8 Millimeter |
| Length | 150 Millimeter |
| Width | 0.8 Millimeter |
| Length | 150 Millimeter |
| Width | 0.8 Millimeter |
| Length | 150 Millimeter |
| Width | 0.8 Millimeter |
| Length | 150 Millimeter |
| Width | 0.8 Millimeter |
| Length | 150 Millimeter |
| Width | 0.8 Millimeter |
| Length | 150 Millimeter |
| Width | 0.8 Millimeter |
| Length | 150 Millimeter |
| Width | 0.8 Millimeter |
| Length | 150 Millimeter |
| Width | 0.8 Millimeter |
| Length | 150 Millimeter |
| Width | 0.8 Millimeter |
| Length | 150 Millimeter |
| Width | 0.8 Millimeter |
| Length | 150 Millimeter |
| Width | 0.8 Millimeter |
| Length | 150 Millimeter |
| Width | 0.8 Millimeter |
| Length | 150 Millimeter |
| Width | 0.8 Millimeter |
| Length | 150 Millimeter |
| Width | 0.8 Millimeter |
| Length | 150 Millimeter |
| Width | 0.8 Millimeter |
| Length | 150 Millimeter |
| Width | 0.8 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | E302OPII0815B9 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[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
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-02-15 |
| 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 |