FDA.report

GPC

Primary DI
08904400201208
Brand
GPC
Company
GPC MEDICAL LIMITED
Model
IBS745
Device description
Screw Driver - Lane's Type
Published
2024-05-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HXXScrewdriver

Product Code Classifications

CodeDeviceSpecialtyClass
HXXScrewdriverOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08904400201208PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08904400201208089044002012088904400201208

GMDN Terms

TermDefinition
General external orthopaedic fixation system implantation kit, reusableA collection of mostly instruments intended to be used to manipulate and prepare soft-tissue and bone for the adjustment or placement of the implantable components of an external orthopaedic fixation system in various skeletal areas (e.g., bones of limbs, spine, pelvis, craniomaxillofacial areas). It is a non-dedicated device that includes various metallic and/or plastic reusable devices (e.g., retractors, rods, clamps, drills, pins, cutters, screwdrivers, guides, tighteners) that are specific to the fixation system applied; the implant(s) is not included. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
9205302602info@gpcmedical.com

Regulatory Flags

DUNS number
915882579
Device count
1
DM exempt
false
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 DIBrandModelCatalogPublished
08904400203394GPCGOS1439S2025-09-19
08904400208689GPCIBP637.0452025-09-19
08904400210903GPC900.15.012025-09-19
08904400210927GPC900.15.032025-09-19
08904400210934GPC900.15.042025-09-19
08904400210941GPC900.15.052025-09-19
08904400210958GPC900.15.062025-09-19
08904400211351GPCBTD1130.25.1802025-09-19
08904400211412GPCBTD1130.32.1952025-09-19
08904400211443GPCBTD1130.35.2002025-09-19
08904400211481GPCBTD1130.45.1952025-09-19
08904400224139GPCS-HS-SD1434.452025-09-19
08904400224245GPCS-HS-SD1434.652025-09-19
08905892010033GPCPFA10.17T2025-09-19
08905892010040GPCPFA10.20T2025-09-19
08905892010057GPCPFA10.24T2025-09-19
08905892010064GPCPFA11.17T2025-09-19
08905892010071GPCPFA11.20T2025-09-19
08905892010088GPCPFA11.24T2025-09-19
08905892010095GPCPFA12.17T2025-09-19

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00190776418328MillenniumAvalign Technologies, Inc.HXX2026-03-23
00199150039524n/aMEDTRONIC SOFAMOR DANEK, INC.HXX2026-03-22
00199150067459Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-03-20
B922F004800208ACURA Stabilization SystemINDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITEDHXX2026-03-11
G832F00500340ACURA Stabilization SystemBioalign Inc.HXX2026-03-09
G832F00503040ACURA Stabilization SystemBioalign Inc.HXX2026-03-09
00840194498975Response 5.5/6.0ORTHOPEDIATRICS CORP.HXX2026-03-03
00840194498982Response 5.5/6.0ORTHOPEDIATRICS CORP.HXX2026-03-03
00810076338545Momentum MIS - Modified InstrumentUlrich Medical Usa, Inc.HXX2026-03-02
00199150066902Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-02-28
03662663128780PathFinder NXT Minimally Invasive Pedicle Screw SystemHighridge Medical, LLCHXX2026-02-11
03662663129084Lineum Occipito-Cervico-Thoracic (OCT) Spinal Fixation SystemHighridge Medical, LLCHXX2026-02-11
00810112597493TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHXX2026-02-10
00810112599756TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHXX2026-02-10
10886982351586NASynthes GmbHHXX2026-02-10
10886982351593NASynthes GmbHHXX2026-02-10
00840180545225General InstrumentsALPHATEC SPINE, INC.HXX2026-01-29
10885862657060CSBExactech, Inc.HXX2026-01-28
00840194498128Response Spine SystemORTHOPEDIATRICS CORP.HXX2026-01-22
00888118145871LEVEL ONEKLS-Martin L.P.HXX2026-01-19
08800308499696INNOVERSE Spinal SystemCG MedTech Co.,Ltd.HXX2026-01-19
07640332471548PERLA ® TLSpineArt SAHXX2026-01-05
00840180543917General InstrumentsALPHATEC SPINE, INC.HXX2025-12-31
00840194495189Response 5.5/6.0ORTHOPEDIATRICS CORP.HXX2025-12-31
00199150060115Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2025-12-29
00199150062898Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2025-12-29
00888480489849Solitaire Cervical Spacer SystemHighridge Medical, LLCHXX2025-12-29
00888480489856Solitaire Cervical Spacer SystemHighridge Medical, LLCHXX2025-12-29
00888480489863Solitaire Cervical Spacer SystemHighridge Medical, LLCHXX2025-12-29
00888480623151Solitaire Cervical Spacer SystemHighridge Medical, LLCHXX2025-12-29