EXCELSIUS GPS
GUDID 00193982192587
Leksell Frame Base Adapter
GLOBUS MEDICAL, INC.
Robotic surgical system| Primary Device ID | 00193982192587 |
| NIH Device Record Key | 00635de4-107f-451a-ab58-d8b74c824c7d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EXCELSIUS GPS |
| Version Model Number | 6143.1920 |
| Company DUNS | 139105691 |
| Company Name | GLOBUS MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | false |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00193982192587 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K200047
FDA Product Code
| OLO | Orthopedic stereotaxic instrument |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00193982192587]
Moist Heat or Steam Sterilization
[00193982192587]
Moist Heat or Steam Sterilization
[00193982192587]
Moist Heat or Steam Sterilization
[00193982192587]
Moist Heat or Steam Sterilization
[00193982192587]
Moist Heat or Steam Sterilization
[00193982192587]
Moist Heat or Steam Sterilization
[00193982192587]
Moist Heat or Steam Sterilization
[00193982192587]
Moist Heat or Steam Sterilization
[00193982192587]
Moist Heat or Steam Sterilization
[00193982192587]
Moist Heat or Steam Sterilization
[00193982192587]
Moist Heat or Steam Sterilization
[00193982192587]
Moist Heat or Steam Sterilization
[00193982192587]
Moist Heat or Steam Sterilization
[00193982192587]
Moist Heat or Steam Sterilization
[00193982192587]
Moist Heat or Steam Sterilization
[00193982192587]
Moist Heat or Steam Sterilization
[00193982192587]
Moist Heat or Steam Sterilization
[00193982192587]
Moist Heat or Steam Sterilization
[00193982192587]
Moist Heat or Steam Sterilization
[00193982192587]
Moist Heat or Steam Sterilization
[00193982192587]
Moist Heat or Steam Sterilization
[00193982192587]
Moist Heat or Steam Sterilization
[00193982192587]
Moist Heat or Steam Sterilization
[00193982192587]
Moist Heat or Steam Sterilization
[00193982192587]
Moist Heat or Steam Sterilization
[00193982192587]
Moist Heat or Steam Sterilization
[00193982192587]
Moist Heat or Steam Sterilization
[00193982192587]
Moist Heat or Steam Sterilization
[00193982192587]
Moist Heat or Steam Sterilization
[00193982192587]
Moist Heat or Steam Sterilization
[00193982192587]
Moist Heat or Steam Sterilization
[00193982192587]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-10-01 |
| Device Publish Date | 2021-09-23 |
On-Brand Devices [EXCELSIUS GPS]
| 00889095998511 | End Effector Sleeve, 15mm |
| 00889095998504 | End Effector Sleeve, 17mm |
| 00889095998498 | Cannula A, 9mm x 250mm |
| 00889095998481 | Ball tip Probe |
| 00889095995176 | 6.35 Rod Attachment, Long |
| 00889095995169 | 6.35 Rod Attachment, Short |
| 00889095375596 | SI-LOK Drill, 7.5mm, GPS |
| 00193982143459 | RISE Torque Limiting Driver, 2.0Nm |
| 00193982143299 | Inserter Body, RISE/CALIBER Inserter, GPS |
| 00193982143282 | CALIBER Torque Limiting Driver, 2.0Nm |
| 00193982143268 | CALIBER Sleeve, RISE/CALIBER Inserter, GPS |
| 00193982143251 | CALIBER Fork, 12mm, RISE/CALIBER Inserter, GPS |
| 00193982143244 | CALIBER Fork, 10mm, RISE/CALIBER Inserter, GPS |
| 00193982143237 | Verification Adapter, CALIBER Inserter Fork, 12mm |
| 00193982143220 | Verification Adapter, CALIBER Inserter Fork, 10mm |
| 00193982143213 | RISE Sleeve, RISE/CALIBER Inserter, GPS |
| 00193982143206 | RISE Fork, 12mm, RISE/CALIBER Inserter, GPS |
| 00193982143190 | RISE Fork, 10mm, RISE/CALIBER Inserter, GPS |
| 00193982143183 | RISE Fork, 8mm, RISE/CALIBER Inserter, GPS |
| 00193982143176 | Verification Adapter, RISE Inserter Fork, 12mm |
| 00193982143169 | Verification Adapter, RISE Inserter Fork, 10mm |
| 00193982143152 | Verification Adapter, RISE Inserter Fork, 8mm |
| 00193982143107 | Torque-Limiting Driver, 3.0Nm, RISE-L/ELSA Inserter |
| 00193982143091 | RISE-L/ELSA Inserter, GPS |
| 00193982143084 | Verification Adapter, RISE-L/ELSA Inserter |
| 00193982143077 | Wrench, RISE-L/ELSA Inserter |
| 00193982143053 | Dilator Array, GPS |
| 00193982143046 | Array T-Handle, 90°, Grey 6, GPS |
| 00193982143039 | Array T-Handle, 90°, Purple 5, GPS |
| 00193982143022 | Array Handle, 180°, Blue 4, GPS |
| 00193982143015 | Array Handle, 180°, Green 3, GPS |
| 00193982143008 | Array Handle, 180°, Gold 2, GPS |
| 00193982142995 | Array Handle, 180°, Red 1, GPS |
| 00193982142926 | Posterior Trial, 10 x 22mm, 15mm, GPS |
| 00193982142919 | Posterior Trial, 10 x 22mm, 14mm, GPS |
| 00193982142902 | Posterior Trial, 10 x 22mm, 13mm, GPS |
| 00193982142896 | Posterior Trial, 10 x 22mm, 12mm, GPS |
| 00193982142889 | Posterior Trial, 10 x 22mm, 11mm, GPS |
| 00193982142872 | Posterior Trial, 10 x 22mm, 10mm, GPS |
| 00193982142865 | Posterior Trial, 10 x 22mm, 9mm, GPS |
| 00193982142858 | Posterior Trial, 10 x 22mm, 8mm, GPS |
| 00193982142841 | Posterior Trial, 10 x 22mm, 7mm, GPS |
| 00193982142834 | Posterior Trial, 10 x 22mm, 6mm, GPS |
| 00193982142827 | Posterior Trial, 10 x 22mm, 5mm, GPS |
| 00193982142797 | Posterior Trial, 8 x 22mm, 15mm, GPS |
| 00193982142780 | Posterior Trial, 8 x 22mm, 14mm, GPS |
| 00193982142773 | Posterior Trial, 8 x 22mm, 13mm, GPS |
| 00193982142766 | Posterior Trial, 8 x 22mm, 12mm, GPS |
| 00193982142759 | Posterior Trial, 8 x 22mm, 11mm, GPS |
| 00193982142742 | Posterior Trial, 8 x 22mm, 10mm, GPS |
Trademark Results [EXCELSIUS GPS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EXCELSIUS GPS 87074053 5365778 Live/Registered |
Globus Medical Inc. 2016-06-16 |
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