| Primary Device ID | E302BIS45119 |
| NIH Device Record Key | faaa7f15-ed51-4be8-92f5-eca5d41c9e22 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Activa Instrument |
| Version Model Number | B-IS-4511 |
| Catalog Number | B-IS-4511 |
| 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 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | E302BIS45119 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[E302BIS45119]
Moist Heat or Steam Sterilization
[E302BIS45119]
Moist Heat or Steam Sterilization
[E302BIS45119]
Moist Heat or Steam Sterilization
[E302BIS45119]
Moist Heat or Steam Sterilization
[E302BIS45119]
Moist Heat or Steam Sterilization
[E302BIS45119]
Moist Heat or Steam Sterilization
[E302BIS45119]
Moist Heat or Steam Sterilization
[E302BIS45119]
Moist Heat or Steam Sterilization
[E302BIS45119]
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 | 2016-08-23 |
| E302BISC45059 | Double drill sleeve Ø4.5/3.5 mm, for 4.0/4.5 mm cannulated screws |
| E302BISC35059 | Double drill sleeve Ø2.7/3.5 mm, for 3.5 mm cannulated screws |
| E302BIS65059 | Protection sheath |
| E302BIS45059 | Double drill sleeve Ø3.2/4.5 mm, for 4.5mm screws |
| E302BIS35059 | Double drill sleeve Ø2.5/3.5 mm, for 3.5mm screws |
| E302BIS27059 | Double drill sleeve Ø2.0/2.7 mm, for 2.7mm screws |
| E302BIS20059 | Double drill sleeve Ø1.5/2.0 mm, for 2.0mm screws |
| E302BISS10009 | ActivaScrew™ Instrument Set |
| E302BISC90339 | HEX shaft, for 4.0/4.5 mm cannulated screws |
| E302BISC90329 | HEX shaft, for 3.5 mm cannulated screws |
| E302BISC90209 | Depth gauge, for cannulated screws |
| E302BISC90139 | Large handle, cannulated, quick coupling |
| E302BISC90009 | Sterilization tray, for ActivaScrew™ Cannulated instruments |
| E302BISC45049 | Countersink, for cannulated screws |
| E302BISC45039 | Holding sleeve, for 4.0/4.5mm cannulated screws |
| E302BISC45029 | Direct driver, for 4.0/4.5 mm cannulated screws |
| E302BISC45019 | Tap Ø4.5 mm, for 4.5 mm cannulated screws |
| E302BISC45009 | Drill bit Ø3.5 mm, for 4.5 mm cannulated screws, quick coupling |
| E302BISC40019 | Tap Ø4.0 mm, for 4.0 mm cannulated screws |
| E302BISC40009 | Drill bit Ø3.2 mm, for 4.0 mm cannulated screws, quick coupling |
| E302BISC35029 | Direct driver, for 3.5 mm cannulated screws |
| E302BISC35019 | Tap Ø3.5 mm, for 3.5 mm cannulated screws |
| E302BISC35009 | Drill bit Ø2.7 mm, for 3.5 mm cannulated screws, quick coupling |
| E302BISC16029 | K-wire Ø1.6 mm, length 300 mm, trocar tip, measuring ring at 150 mm, for 4/4.5 mm cannulated sc |
| E302BISC16019 | K-wire Ø1.6 mm, length 150 mm, trocar tip, for 4.0/4.5mm cannulated screws |
| E302BISC16009 | K-wire Ø1.6 mm, length 150 mm, threaded tip, for 4.0/4.5mm cannulated screws |
| E302BISC12519 | K-wire Ø1.25 mm, length 150 mm, trocar tip, for 3.5mm cannulated screws |
| E302BISC12509 | K-wire Ø1.25 mm, length 150 mm, threaded tip, for 3.5mm cannulated screws |
| E302BISC10009 | ActivaScrew™ Cannulated Instrument Set |
| E302BIS90339 | HEX shaft, for 4.5mm screws |
| E302BIS90329 | HEX shaft, for 2.0/2.7/3.5 mm screws |
| E302BIS90219 | Depth gauge, for 4.5 mm screws |
| E302BIS90209 | Depth gauge, for 2.0/2.7/3.5 mm screws |
| E302BIS90129 | Small handle, quick coupling |
| E302BIS90109 | T-handle, quick coupling |
| E302BIS90009 | Sterilization tray, for ActivaScrew™ instruments |
| E302BIS45119 | Tap Ø4.5 mm, for 4.5 mm screws up to length 45 mm |
| E302BIS45109 | Drill bit Ø3.2 mm, for 4.5 mm screws up to length 70 mm, quick coupling |
| E302BIS45049 | Countersink, for 4.5mm screws |
| E302BIS45039 | Holding sleeve, for 4.5mm screws |
| E302BIS45019 | Tap Ø4.5 mm, for 4.5 mm screws up to length 90 mm |
| E302BIS45009 | Drill bit Ø3.2 mm, for 4.5 mm screws up to length 90 mm, quick coupling |
| E302BIS35049 | Countersink, for 2.7/3.5 mm screws |
| E302BIS35039 | Holding sleeve, for 2.0/2.7/3.5mm screws |
| E302BIS35019 | Tap Ø3.5 mm, for 3.5 mm screws |
| E302BIS35009 | Drill bit Ø2.5mm, for 3.5 mm screws, quick coupling |
| E302BIS27019 | Tap Ø2.7 mm, for 2.7 mm screws |
| E302BIS27009 | Drill bit Ø2.0 mm, for 2.7 mm screws, quick coupling |
| E302BIS20049 | Countersink, for 2.0 mm screws |
| E302BIS20019 | Tap Ø2.0 mm, for 2.0 mm screws |