GPS 521-11-04

GUDID 10885862092830

SCREWDRIVER, HEX, DIAMETER 3.5mm

Exactech, Inc.

Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system
Primary Device ID10885862092830
NIH Device Record Key65d9add3-96e8-475e-8813-cda250397972
Commercial Distribution StatusIn Commercial Distribution
Brand NameGPS
Version Model Number521-11-04
Catalog Number521-11-04
Company DUNS157565946
Company NameExactech, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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

Device Dimensions

Outer Diameter3.5 Millimeter
Outer Diameter3.5 Millimeter
Outer Diameter3.5 Millimeter
Outer Diameter3.5 Millimeter
Outer Diameter3.5 Millimeter
Outer Diameter3.5 Millimeter
Outer Diameter3.5 Millimeter
Outer Diameter3.5 Millimeter
Outer Diameter3.5 Millimeter
Outer Diameter3.5 Millimeter
Outer Diameter3.5 Millimeter
Outer Diameter3.5 Millimeter
Outer Diameter3.5 Millimeter
Outer Diameter3.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS110885862092830 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HAWNeurological stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10885862092830]

Moist Heat or Steam Sterilization

[10885862092830]

Moist Heat or Steam Sterilization

[10885862092830]

Moist Heat or Steam Sterilization

[10885862092830]

Moist Heat or Steam Sterilization

[10885862092830]

Moist Heat or Steam Sterilization

[10885862092830]

Moist Heat or Steam Sterilization

[10885862092830]

Moist Heat or Steam Sterilization

[10885862092830]

Moist Heat or Steam Sterilization

[10885862092830]

Moist Heat or Steam Sterilization

[10885862092830]

Moist Heat or Steam Sterilization

[10885862092830]

Moist Heat or Steam Sterilization

[10885862092830]

Moist Heat or Steam Sterilization

[10885862092830]

Moist Heat or Steam Sterilization

[10885862092830]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-08-26
Device Publish Date2022-08-18

On-Brand Devices [GPS]

10885862606891GPS GUIDE NO STYLUS
10885862564832GPS TRU 3.5MM BALL HEX DRIVER ZHUDSON
10885862564801GPS COLLARED 3.2MM DRILL RTG
10885862564788GPS TRU FINISHING GUIDE PIN ADAPTOR
10885862564771GPS TRU REAL TIME GUIDE COUPLER
10885862564757GPS TRU REAL TIME GUIDE
10885862564740GPS FEMORAL ADJUSTABLE RESECTION GUIDE
10885862564733GPS RIGHT TIBIAL BASE
10885862564726GPS RIGHT TIBIAL ADJUST RESECTION GUIDE
10885862564719GPS LEFT TIBIAL BASE
10885862564702GPS LEFT TIBIAL ADJUST RESECTION GUIDE
10885862542038SHOULDER GPS IMPACTOR HANDLE
10885862527776OFF SHLDR GPS BLOCK R
10885862527769OFF SHLDR GPS BLOCK L
10885862319272SHLDR GPS RVRS DRILL KIT
10885862319197SHOULDR GPS HEX PINS KIT
10885862314338SHLDR GPS CAN CNTR DRILL
10885862314321SHOULDER GPS CNTR DRILL
10885862311238GPS MINI TRAY LID
10885862310040GPS MODIFIED TIBIAL CUTTING BLOCK UNCAPTURED
10885862310033GPS MODIFIED TIBIAL CUTTING BLOCK
10885862308238SHLDR GPS HUDSON ADAPTER
10885862308146SHLDR GPS MODULAR DRIVER
10885862289018GPS TRACKER TRAY TRACKERS ONLY
10885862289001GPS LPI UPPER TRAY INSTRUMENT TRAY
10885862288998GPS LPI GENERIC INSTRUMENT TRAY
10885862288981GPS UPPER TRAY INSTRUMENT TRAY
10885862288974GPS/LPI CORE INSTRUMENT TRAY
10885862288950LID, GPS
10885862238160INSTRUMENT TRAY, SLED, TENSOR, GPS
10885862238153INSTRUMENT TRAY, SLED, FEMORAL, GPS 4-IN-1 POSITION GUIDE
10885862238146INSTRUMENT TRAY, SLED, GPS, EXTERNAL TRACKER FIXATOR
10885862238139INSTRUMENT TRAY, SLED, TIBIAL, GPS
10885862238122INSTRUMENT TRAY, SLED, FEMORAL, GPS
10885862238115GPS GENERIC SPACE SLED
10885862238108INSTRUMENT TRAY, GPS
10885862092984SLED, TIBIAL GPS BLOCK BASE, L&R
10885862092960GPS SECONDARY MODULAR
10885862092953GPS PRIMARY MODULAR SLED INSTRUMENT TRAY
10885862564825External Tracker Fixator 30 Deg
10885862564818External Tracker Fixator 0 Deg
10885862308184SHOULDER GPS DRILL, 3.2mm
10885862308177Shoulder GPS 2.9mm Drill Bit
10885862092830SCREWDRIVER, HEX, DIAMETER 3.5mm
10885862539229SHDLR GPS PEG DRL GD R16
10885862539212SHDLR GPS PEG DRL GD L16
10885862539205SHDLR GPS PEG DRL GD R 8
10885862539199SHDLR GPS PEG DRL GD L 8
10885862539182SHDLR GPS PEG DRL GD R
10885862539175SHDLR GPS PEG DRL GD L
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