ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

GUDID 00193982567446

Multi-Tool with AO Connection

GLOBUS MEDICAL, INC.

Orthopaedic surgical procedure kit, non-medicated, reusable
Primary Device ID00193982567446
NIH Device Record Key70c65c67-4912-42bb-9841-1f7cb76ef5ff
Commercial Distribution StatusIn Commercial Distribution
Brand NameORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Version Model Number6173.0114
Company DUNS139105691
Company NameGLOBUS MEDICAL, INC.
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100193982567446 [Primary]

FDA Product Code

LXHOrthopedic manual surgical instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00193982567446]

Moist Heat or Steam Sterilization


[00193982567446]

Moist Heat or Steam Sterilization


[00193982567446]

Moist Heat or Steam Sterilization


[00193982567446]

Moist Heat or Steam Sterilization


[00193982567446]

Moist Heat or Steam Sterilization


[00193982567446]

Moist Heat or Steam Sterilization


[00193982567446]

Moist Heat or Steam Sterilization


[00193982567446]

Moist Heat or Steam Sterilization


[00193982567446]

Moist Heat or Steam Sterilization


[00193982567446]

Moist Heat or Steam Sterilization


[00193982567446]

Moist Heat or Steam Sterilization


[00193982567446]

Moist Heat or Steam Sterilization


[00193982567446]

Moist Heat or Steam Sterilization


[00193982567446]

Moist Heat or Steam Sterilization


[00193982567446]

Moist Heat or Steam Sterilization


[00193982567446]

Moist Heat or Steam Sterilization


[00193982567446]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-04
Device Publish Date2024-06-26

Devices Manufactured by GLOBUS MEDICAL, INC.

00193982184506 - EXCELSIUS3D2024-07-04 Excelsius3D
00193982184537 - EXCELSIUS3D2024-07-04 Mobile Monitor
00193982567446 - ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2024-07-04Multi-Tool with AO Connection
00193982567446 - ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2024-07-04 Multi-Tool with AO Connection
00193982458157 - QUARTEX2024-04-09 Power Rod Gripper, 3.5mm Rod
00193982458164 - QUARTEX2024-04-09 Power Rod Gripper, 4.0mm Rod
00193982511005 - QUARTEX2024-04-09 Rigid Ball Tip Probe
00193982511012 - QUARTEX2024-04-09 Locking Rigid Driver
00193982535636 - ADIRA2024-04-09 ADIRA Plate Inserter, Threaded Shaft

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