UCR 91-0511

GUDID 10889981079987

3mm Hex Shaft

SEASPINE ORTHOPEDICS CORPORATION

Orthopaedic implant driver
Primary Device ID10889981079987
NIH Device Record Keya892603c-ae11-48ad-8d8a-b52723514e8f
Commercial Distribution StatusIn Commercial Distribution
Brand NameUCR
Version Model Number91-0511
Catalog Number91-0511
Company DUNS079840876
Company NameSEASPINE ORTHOPEDICS CORPORATION
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 Usetrue
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+1(760)727-8399
Emailcustsvcspine@seaspine.com
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS110889981079987 [Primary]

FDA Product Code

LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10889981079987]

Moist Heat or Steam Sterilization


[10889981079987]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-05-02

On-Brand Devices [UCR]

10889981119492UCR 2 Instrument
10889981082130Rod Rotator, 5.5mm Dia
108899810821235.5 Power Rod Gripper
10889981082109Hook Inserter
10889981081072Tap 6.0mm, Modular (for 6.5mm Screw)
10889981080402COMPRESSOR
10889981080396DISTRACTOR
10889981080372Reduction THD Driver 5.5/6.75 mm
108899810803654mm Hex, Large Axial Driver
108899810803583mm Hex, Large Axial Driver
108899810803413mm Driver, Small T-Handle
10889981080334Static T-Handle, 4mm
10889981080327Static T-Handle, 3mm
10889981080310CrossBar Limiting Hex Driver
10889981080303CROSSBAR HEX DRIVER
108899810802805.0 mm Trial Rod Silicone Covered
108899810802735.0 mm Trial Rod Silicone Covered
10889981080266Deflection Beam Torque Wrench
10889981080259COMBINATION WRENCH 3/16"
10889981080242Tabletop Rod Cutter
10889981080235LIMITING TORQUE T-HANDLE
10889981080228Ratcheting T-Handle
10889981080211RATCHETING DRIVER HANDLE
10889981080204Rod Cutter
1088998108018120mm Jaw Set Distractor/Compressor (Set of Two)
10889981080174Jaw Set 5.5mm - 6.35mm (Set of Two)
10889981080167PARALLEL COMPRESSOR WITH INTERCHANGEABLE HNDLS
10889981080150PARALLEL DISTRACTOR WITH INTERCHANGEABLE HNDLS
10889981080143FRENCH ROD BENDER
10889981080129Pedicle Sounder, Straight
10889981080105Curved Probe
10889981080099Straight Probe
10889981080082Bone Awl
10889981080075Solid Tap, 8.0mm
10889981080068Tap, 8.0mm
10889981080051Solid Tap, 6.75mm
10889981080044Tap, 7.0mm
10889981080037Solid Tap, 5.5mm
10889981080020Tap, 5.5mm
10889981080013UCR Instrument Tray
10889981080006UCR Implant Tray
108899810799944MM HEX SHAFT
108899810799873mm Hex Shaft
10889981079956Rod Fork
10889981079949Rocker
10889981079932Simple Tap Sleeve
10889981079925X-RAY MARKER, LONG
10889981079918X-RAY MARKER, SHORT
10889981079895Hex Tip UCR Inserter, 8.0
10889981079888Fixed Tip Inserter Sleeve, 8.0

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