Activa Instrument B-IS-4510

GUDID E302BIS45109

Drill bit Ø3.2 mm, for 4.5 mm screws up to length 70 mm, quick coupling

Bioretec Oy

Fluted surgical drill bit, reusable
Primary Device IDE302BIS45109
NIH Device Record Key3143991e-a0a8-4d71-9e00-ce2ece15d095
Commercial Distribution StatusIn Commercial Distribution
Brand NameActiva Instrument
Version Model NumberB-IS-4510
Catalog NumberB-IS-4510
Company DUNS368715301
Company NameBioretec Oy
Device Count1
DM Exemptfalse
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

Device Dimensions

Width3.2 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE302BIS45109 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[E302BIS45109]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-11-22
Device Publish Date2016-08-23

On-Brand Devices [Activa Instrument]

E302BISC45059Double drill sleeve Ø4.5/3.5 mm, for 4.0/4.5 mm cannulated screws
E302BISC35059Double drill sleeve Ø2.7/3.5 mm, for 3.5 mm cannulated screws
E302BIS65059Protection sheath
E302BIS45059Double drill sleeve Ø3.2/4.5 mm, for 4.5mm screws
E302BIS35059Double drill sleeve Ø2.5/3.5 mm, for 3.5mm screws
E302BIS27059Double drill sleeve Ø2.0/2.7 mm, for 2.7mm screws
E302BIS20059Double drill sleeve Ø1.5/2.0 mm, for 2.0mm screws
E302BISS10009ActivaScrew™ Instrument Set
E302BISC90339HEX shaft, for 4.0/4.5 mm cannulated screws
E302BISC90329HEX shaft, for 3.5 mm cannulated screws
E302BISC90209Depth gauge, for cannulated screws
E302BISC90139Large handle, cannulated, quick coupling
E302BISC90009Sterilization tray, for ActivaScrew™ Cannulated instruments
E302BISC45049Countersink, for cannulated screws
E302BISC45039Holding sleeve, for 4.0/4.5mm cannulated screws
E302BISC45029Direct driver, for 4.0/4.5 mm cannulated screws
E302BISC45019Tap Ø4.5 mm, for 4.5 mm cannulated screws
E302BISC45009Drill bit Ø3.5 mm, for 4.5 mm cannulated screws, quick coupling
E302BISC40019Tap Ø4.0 mm, for 4.0 mm cannulated screws
E302BISC40009Drill bit Ø3.2 mm, for 4.0 mm cannulated screws, quick coupling
E302BISC35029Direct driver, for 3.5 mm cannulated screws
E302BISC35019Tap Ø3.5 mm, for 3.5 mm cannulated screws
E302BISC35009Drill bit Ø2.7 mm, for 3.5 mm cannulated screws, quick coupling
E302BISC16029K-wire Ø1.6 mm, length 300 mm, trocar tip, measuring ring at 150 mm, for 4/4.5 mm cannulated sc
E302BISC16019K-wire Ø1.6 mm, length 150 mm, trocar tip, for 4.0/4.5mm cannulated screws
E302BISC16009K-wire Ø1.6 mm, length 150 mm, threaded tip, for 4.0/4.5mm cannulated screws
E302BISC12519K-wire Ø1.25 mm, length 150 mm, trocar tip, for 3.5mm cannulated screws
E302BISC12509K-wire Ø1.25 mm, length 150 mm, threaded tip, for 3.5mm cannulated screws
E302BISC10009ActivaScrew™ Cannulated Instrument Set
E302BIS90339HEX shaft, for 4.5mm screws
E302BIS90329HEX shaft, for 2.0/2.7/3.5 mm screws
E302BIS90219Depth gauge, for 4.5 mm screws
E302BIS90209Depth gauge, for 2.0/2.7/3.5 mm screws
E302BIS90129Small handle, quick coupling
E302BIS90109T-handle, quick coupling
E302BIS90009Sterilization tray, for ActivaScrew™ instruments
E302BIS45119Tap Ø4.5 mm, for 4.5 mm screws up to length 45 mm
E302BIS45109Drill bit Ø3.2 mm, for 4.5 mm screws up to length 70 mm, quick coupling
E302BIS45049Countersink, for 4.5mm screws
E302BIS45039Holding sleeve, for 4.5mm screws
E302BIS45019Tap Ø4.5 mm, for 4.5 mm screws up to length 90 mm
E302BIS45009Drill bit Ø3.2 mm, for 4.5 mm screws up to length 90 mm, quick coupling
E302BIS35049Countersink, for 2.7/3.5 mm screws
E302BIS35039Holding sleeve, for 2.0/2.7/3.5mm screws
E302BIS35019Tap Ø3.5 mm, for 3.5 mm screws
E302BIS35009Drill bit Ø2.5mm, for 3.5 mm screws, quick coupling
E302BIS27019Tap Ø2.7 mm, for 2.7 mm screws
E302BIS27009Drill bit Ø2.0 mm, for 2.7 mm screws, quick coupling
E302BIS20049Countersink, for 2.0 mm screws
E302BIS20019Tap Ø2.0 mm, for 2.0 mm screws

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.