FDA.reportPublic FDA data

CASSIOPEIA ACP

Primary DI
08806395497997
Brand
CASSIOPEIA ACP
Company
GS Medical Co., Ltd.
Model
GS142-5200
Catalog number
GS142-5200
Device description
Temporary Fixation Pin Driver
Published
2020-09-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
08806395497997PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806395497997088063954979978806395497997

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
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800322740446Anyplus II Spinal Fixation System3885-75403885-75402025-12-23
08800322740453Anyplus II Spinal Fixation System3885-75453885-75452025-12-23
08800322740460Anyplus II Spinal Fixation System3885-75503885-75502025-12-23
08800322740477Anyplus II Spinal Fixation System3885-75553885-75552025-12-23
08800322740484Anyplus II Spinal Fixation System3885-75603885-75602025-12-23
08800322740491Anyplus II Spinal Fixation System3885-75653885-75652025-12-23
08800322740507Anyplus II Spinal Fixation System3885-75703885-75702025-12-23
08800322740514Anyplus II Spinal Fixation System3885-75753885-75752025-12-23
08800322740521Anyplus II Spinal Fixation System3885-75803885-75802025-12-23
08800322740538Anyplus II Spinal Fixation System3885-75853885-75852025-12-23
08800322740545Anyplus II Spinal Fixation System3885-75903885-75902025-12-23
08800322740552Anyplus II Spinal Fixation System3885-75953885-75952025-12-23
08800322740569Anyplus II Spinal Fixation System3885-75003885-75002025-12-23
08800322740576Anyplus II Spinal Fixation System3885-80303885-80302025-12-23
08800322740583Anyplus II Spinal Fixation System3885-80353885-80352025-12-23
08800322740590Anyplus II Spinal Fixation System3885-80403885-80402025-12-23
08800322740606Anyplus II Spinal Fixation System3885-80453885-80452025-12-23
08800322740613Anyplus II Spinal Fixation System3885-80503885-80502025-12-23
08800322740620Anyplus II Spinal Fixation System3885-80553885-80552025-12-23
08800322740637Anyplus II Spinal Fixation System3885-80603885-80602025-12-23

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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
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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
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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
00860007230059Insurgical, Inc.Insurgical, Inc.GFC2025-01-17
00860007230066Insurgical, Inc.Insurgical, Inc.GFC2025-01-17
10886982347459NASynthes GmbHGFC2024-08-14