Primary Device ID | E302BISC35019 |
NIH Device Record Key | 72ac0808-dc14-4282-a3e2-2d1fe7a9cd4d |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Activa Instrument |
Version Model Number | B-ISC-3501 |
Catalog Number | B-ISC-3501 |
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 | E302BISC35019 [Primary] |
LXH | Orthopedic Manual Surgical Instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[E302BISC35019]
Moist Heat or Steam Sterilization
[E302BISC35019]
Moist Heat or Steam Sterilization
[E302BISC35019]
Moist Heat or Steam Sterilization
[E302BISC35019]
Moist Heat or Steam Sterilization
[E302BISC35019]
Moist Heat or Steam Sterilization
[E302BISC35019]
Moist Heat or Steam Sterilization
[E302BISC35019]
Moist Heat or Steam Sterilization
[E302BISC35019]
Moist Heat or Steam Sterilization
[E302BISC35019]
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 |