FDA.reportPublic FDA data

CASSIOPEIA Cervical Plate System

Primary DI
08800104058714
Brand
CASSIOPEIA Cervical Plate System
Company
GS Medical Co., Ltd.
Model
GS142-5210
Catalog number
GS142-5210
Device description
Temporary Fixation Pin Driver
Published
2025-03-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GFCDriver, Surgical, Pin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFCDriver, Surgical, PinGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800104058714PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800104058714088001040587148800104058714

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+82432377393udimail@gsmedi.com

Regulatory Flags#

DUNS number
688385418
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800322693100VEGA Cervical Screw System0866-10300866-10302026-09-30
08800322693117VEGA Cervical Screw System0866-1030-M00866-1030-M02026-09-30
08800322693124VEGA Cervical Screw System0866-10350866-10352026-09-30
08800322693131VEGA Cervical Screw System0866-1035-M00866-1035-M02026-09-30
08800322693148VEGA Cervical Screw System0866-10400866-10402026-09-30
08800322693155VEGA Cervical Screw System0866-1040-M00866-1040-M02026-09-30
08800322693162VEGA Cervical Screw System0866-10450866-10452026-09-30
08800322693179VEGA Cervical Screw System0866-1045-M00866-1045-M02026-09-30
08800322693186VEGA Cervical Screw System0866-10500866-10502026-09-30
08800322693193VEGA Cervical Screw System0866-1050-M00866-1050-M02026-09-30
08800322693209VEGA Cervical Screw System0866-10550866-10552026-09-30
08800322693216VEGA Cervical Screw System0866-1055-M00866-1055-M02026-09-30
08800322693223VEGA Cervical Screw System0866-10600866-10602026-09-30
08800322693230VEGA Cervical Screw System0866-1060-M00866-1060-M02026-09-30
08800322693247VEGA Cervical Screw System0866-10650866-10652026-09-30
08800322693254VEGA Cervical Screw System0866-1065-M00866-1065-M02026-09-30
08800322693261VEGA Cervical Screw System0866-10700866-10702026-09-30
08800322693278VEGA Cervical Screw System0866-1070-M00866-1070-M02026-09-30
08800322693285VEGA Cervical Screw System0866-10750866-10752026-09-30
08800322693292VEGA Cervical Screw System0866-1075-M00866-1075-M02026-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14053613298336Pin DriverGebr. Brasseler GmbH & Co. KGGFC2026-10-09
00840286860390Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.GFC2026-07-09
08806162109436AnyPlus®GS Medical Co., Ltd.GFC2026-01-28
03662663108645Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLCGFC2025-11-12
00842188130304K-WiresTrimed, INC.GFC2025-07-08
00841132197066PediNailORTHOPEDIATRICS CORP.GFC2025-06-05
00840194472401PNP FemurORTHOPEDIATRICS CORP.GFC2025-05-28
00840286842129Consensus Knee System/Revision Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-22
00840286842136Consensus Knee System/Revision Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-22
00840286846714Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-22
00840286855044Consensus Knee System/Revision Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-22
00840286855051Consensus Knee System/Revision Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-22
00840286855068Consensus Knee System/Revision Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-22
00840286855136Consensus Knee System/Revision Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-22
00840286855143Consensus Knee System/Revision Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-22
00840286855150Consensus Knee System/Revision Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-22
00840286855167Consensus Knee System/Revision Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-22
00840286859950Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-22
00840286843867UniSyn Hip SystemShalby Advanced Technologies, Inc.GFC2025-05-20
14053613292136PIN DRIVERGebr. Brasseler GmbH & Co. KGGFC2025-05-19
14053613292143PIN DRIVERGebr. Brasseler GmbH & Co. KGGFC2025-05-19
14053613292150PIN DRIVERGebr. Brasseler GmbH & Co. KGGFC2025-05-19
14053613292167PIN DRIVERGebr. Brasseler GmbH & Co. KGGFC2025-05-19
14053613293164PIN DRIVERGebr. Brasseler GmbH & Co. KGGFC2025-05-15
04053613293167PIN DRIVERGebr. Brasseler GmbH & Co. KGGFC2025-05-15
00840286846707Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-14
04042409452987NAaap Implantate AGGFC2025-02-26
04042409453007NAaap Implantate AGGFC2025-02-26
04042409453021NAaap Implantate AGGFC2025-02-26
04042409453045NAaap Implantate AGGFC2025-02-26