FDA.reportPublic FDA data

CASSIOPEIA ACP

Primary DI
08806395497782
Brand
CASSIOPEIA ACP
Company
GS Medical Co., Ltd.
Model
GS142-1012
Catalog number
GS142-1012
Device description
Drill Bit, 12mm
Published
2020-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTWBit, Drill

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806395497782PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806395497782088063954977828806395497782

GMDN Terms#

Term, Definition table
TermDefinition
Bone tap, reusableA metal surgical instrument designed for cutting internal threads into bone so that the threads facilitate the insertion of bone screws. The screws anchor bone fragments, fixtures and/or other devices to the bone. It is made of high-grade stainless steel and has a helical thread intersected with longitudinal cutting grooves forming the cutting edges at its distal end and may be cannulated. The proximal end typically terminates in a square to which a tapping instrument or extension can be attached. It will typically be manually rotated in order to create a best possible thread. 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09120125220273Shark Screw® drillsurgebright GmbHHTW2026-04-30
08053782783724BRM TOOL VIP SCREWS INSTRUMENTBRM EXTREMITIES SRLHTW2026-04-29
08059386744260Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-06
08059386744277Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-06
08059386742327Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-05
08059386742341Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-05
08059386742358Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-05
08059386742365Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-05
08059386742372Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-05
08059386742389Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-05
08059386742396Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-05
08059386742402Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-05
08059386747957Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-10-27
08053782780464BRM TOOL PRO SCREWS INSTRUMENTBRM EXTREMITIES SRLHTW2025-10-15
08053782780471BRM TOOL PRO SCREWS INSTRUMENTBRM EXTREMITIES SRLHTW2025-10-15
G79151202112817G0WishFIXRed Star Contract Manufacturing Inc.HTW2025-10-06
09120125220044Shark Screw® drillsurgebright GmbHHTW2025-09-16
09120125220051Shark Screw® drillsurgebright GmbHHTW2025-09-16
09120125220068Shark Screw® drillsurgebright GmbHHTW2025-09-16
09120125220075Shark Screw® drillsurgebright GmbHHTW2025-09-16
09120125220082Shark Screw® drillsurgebright GmbHHTW2025-09-16
09120125220099Shark Screw® drillsurgebright GmbHHTW2025-09-16
09120125220105Shark Screw® drillsurgebright GmbHHTW2025-09-16
09120125220112Shark Screw® drillsurgebright GmbHHTW2025-09-16
08809416065601Surgical InstrumentOSTEONIC CO.,Ltd.HTW2025-06-24
08809416065618Surgical InstrumentOSTEONIC CO.,Ltd.HTW2025-06-24
08809416065625Surgical InstrumentOSTEONIC CO.,Ltd.HTW2025-06-24
08809416066905Surgical InstrumentOSTEONIC CO.,Ltd.HTW2025-06-24
08809416066912Surgical InstrumentOSTEONIC CO.,Ltd.HTW2025-06-24
08809416068671Surgical InstrumentOSTEONIC CO.,Ltd.HTW2025-06-24