EXCELSIUS GPS

GUDID 00193982141905

Lateral Scraper, 13mm, GPS

GLOBUS MEDICAL, INC.

Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system
Primary Device ID00193982141905
NIH Device Record Keya7081179-f686-4bdd-bd6a-65621b3d3887
Commercial Distribution StatusIn Commercial Distribution
Brand NameEXCELSIUS GPS
Version Model Number6143.1229
Company DUNS139105691
Company NameGLOBUS MEDICAL, 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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100193982141905 [Primary]
GS100193982141905 [Primary]
GS100193982141905 [Primary]
GS100193982141905 [Primary]
GS100193982141905 [Primary]
GS100193982141905 [Primary]
GS100193982141905 [Primary]
GS100193982141905 [Primary]
GS100193982141905 [Primary]
GS100193982141905 [Primary]
GS100193982141905 [Primary]
GS100193982141905 [Primary]
GS100193982141905 [Primary]
GS100193982141905 [Primary]
GS100193982141905 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic stereotaxic instrument
OLOOrthopedic stereotaxic instrument
OLOOrthopedic stereotaxic instrument
OLOOrthopedic stereotaxic instrument
OLOOrthopedic stereotaxic instrument
OLOOrthopedic stereotaxic instrument
OLOOrthopedic stereotaxic instrument
OLOOrthopedic stereotaxic instrument
OLOOrthopedic stereotaxic instrument
OLOOrthopedic stereotaxic instrument
OLOOrthopedic stereotaxic instrument
OLOOrthopedic stereotaxic instrument
OLOOrthopedic stereotaxic instrument
OLOOrthopedic stereotaxic instrument
OLOOrthopedic stereotaxic instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00193982141905]

Moist Heat or Steam Sterilization


[00193982141905]

Moist Heat or Steam Sterilization


[00193982141905]

Moist Heat or Steam Sterilization


[00193982141905]

Moist Heat or Steam Sterilization


[00193982141905]

Moist Heat or Steam Sterilization


[00193982141905]

Moist Heat or Steam Sterilization


[00193982141905]

Moist Heat or Steam Sterilization


[00193982141905]

Moist Heat or Steam Sterilization


[00193982141905]

Moist Heat or Steam Sterilization


[00193982141905]

Moist Heat or Steam Sterilization


[00193982141905]

Moist Heat or Steam Sterilization


[00193982141905]

Moist Heat or Steam Sterilization


[00193982141905]

Moist Heat or Steam Sterilization


[00193982141905]

Moist Heat or Steam Sterilization


[00193982141905]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-14
Device Publish Date2020-10-06

On-Brand Devices [EXCELSIUS GPS]

00889095998511End Effector Sleeve, 15mm
00889095998504End Effector Sleeve, 17mm
00889095998498Cannula A, 9mm x 250mm
00889095998481Ball tip Probe
008890959951766.35 Rod Attachment, Long
008890959951696.35 Rod Attachment, Short
00889095375596SI-LOK Drill, 7.5mm, GPS
00193982143459RISE Torque Limiting Driver, 2.0Nm
00193982143299Inserter Body, RISE/CALIBER Inserter, GPS
00193982143282CALIBER Torque Limiting Driver, 2.0Nm
00193982143268CALIBER Sleeve, RISE/CALIBER Inserter, GPS
00193982143251CALIBER Fork, 12mm, RISE/CALIBER Inserter, GPS
00193982143244CALIBER Fork, 10mm, RISE/CALIBER Inserter, GPS
00193982143237Verification Adapter, CALIBER Inserter Fork, 12mm
00193982143220Verification Adapter, CALIBER Inserter Fork, 10mm
00193982143213RISE Sleeve, RISE/CALIBER Inserter, GPS
00193982143206RISE Fork, 12mm, RISE/CALIBER Inserter, GPS
00193982143190RISE Fork, 10mm, RISE/CALIBER Inserter, GPS
00193982143183RISE Fork, 8mm, RISE/CALIBER Inserter, GPS
00193982143176Verification Adapter, RISE Inserter Fork, 12mm
00193982143169Verification Adapter, RISE Inserter Fork, 10mm
00193982143152Verification Adapter, RISE Inserter Fork, 8mm
00193982143107Torque-Limiting Driver, 3.0Nm, RISE-L/ELSA Inserter
00193982143091RISE-L/ELSA Inserter, GPS
00193982143084Verification Adapter, RISE-L/ELSA Inserter
00193982143077Wrench, RISE-L/ELSA Inserter
00193982143053Dilator Array, GPS
00193982143046Array T-Handle, 90°, Grey 6, GPS
00193982143039Array T-Handle, 90°, Purple 5, GPS
00193982143022Array Handle, 180°, Blue 4, GPS
00193982143015Array Handle, 180°, Green 3, GPS
00193982143008Array Handle, 180°, Gold 2, GPS
00193982142995Array Handle, 180°, Red 1, GPS
00193982142926Posterior Trial, 10 x 22mm, 15mm, GPS
00193982142919Posterior Trial, 10 x 22mm, 14mm, GPS
00193982142902Posterior Trial, 10 x 22mm, 13mm, GPS
00193982142896Posterior Trial, 10 x 22mm, 12mm, GPS
00193982142889Posterior Trial, 10 x 22mm, 11mm, GPS
00193982142872Posterior Trial, 10 x 22mm, 10mm, GPS
00193982142865Posterior Trial, 10 x 22mm, 9mm, GPS
00193982142858Posterior Trial, 10 x 22mm, 8mm, GPS
00193982142841Posterior Trial, 10 x 22mm, 7mm, GPS
00193982142834Posterior Trial, 10 x 22mm, 6mm, GPS
00193982142827Posterior Trial, 10 x 22mm, 5mm, GPS
00193982142797Posterior Trial, 8 x 22mm, 15mm, GPS
00193982142780Posterior Trial, 8 x 22mm, 14mm, GPS
00193982142773Posterior Trial, 8 x 22mm, 13mm, GPS
00193982142766Posterior Trial, 8 x 22mm, 12mm, GPS
00193982142759Posterior Trial, 8 x 22mm, 11mm, GPS
00193982142742Posterior Trial, 8 x 22mm, 10mm, GPS

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