FDA.reportPublic FDA data

Surgical Instrument

Primary DI
08809265158462
Brand
Surgical Instrument
Company
Jeil Medical Corporation
Model
20-QD-001
Published
2018-09-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GXLScrewdriver, Skullplate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXLScrewdriver, SkullplateNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809265158462PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809265158462088092651584628809265158462

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

Regulatory Flags#

DUNS number
688811603
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800089479450ARIX System Bone Screw35N-SO-L20-TA2026-06-01
08800089479467ARIX System Bone Screw35N-SO-L22-TA2026-06-01
08800089479474ARIX System Bone Screw35N-SO-L24-TA2026-06-01
08800089479481ARIX System Bone Screw35N-SO-L26-TA2026-06-01
08800089479498ARIX System Bone Screw35N-SO-L28-TA2026-06-01
08800089479504ARIX System Bone Screw35N-SO-L30-TA2026-06-01
08800089479511ARIX System Bone Screw35N-SO-L32-TA2026-06-01
08800089479528ARIX System Bone Screw35N-SO-L34-TA2026-06-01
08800089479535ARIX System Bone Screw35N-SO-L36-TA2026-06-01
08800089479542ARIX System Bone Screw35N-SO-L38-TA2026-06-01
08800089479559ARIX System Bone Screw35N-SO-L40-TA2026-06-01
08800089479566ARIX System Bone Screw35N-SO-L42-TA2026-06-01
08800089479573ARIX System Bone Screw35N-SO-L44-TA2026-06-01
08800089479580ARIX System Bone Screw35N-SO-L46-TA2026-06-01
08800089479597ARIX System Bone Screw35N-SO-L48-TA2026-06-01
08800089479603ARIX System Bone Screw35N-SO-L50-TA2026-06-01
08800089479610ARIX System Bone Screw35N-SO-L52-TA2026-06-01
08800089479627ARIX System Bone Screw35N-SO-L56-TA2026-06-01
08800089479634ARIX System Bone Screw35N-SO-L60-TA2026-06-01
08800089479641ARIX System Bone Screw40N-SA-020-T2026-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07610733850365OPERACEPB SWISS TOOLS AGGXL2024-09-24
07610733850372OPERACEPB SWISS TOOLS AGGXL2024-09-24
07610733850464OPERACEPB SWISS TOOLS AGGXL2024-09-24
07610733850556OPERACEPB SWISS TOOLS AGGXL2024-09-24
07610733850563OPERACEPB SWISS TOOLS AGGXL2024-09-24
07610733850600OPERACEPB SWISS TOOLS AGGXL2024-09-24
07610733850617OPERACEPB SWISS TOOLS AGGXL2024-09-24
07610733850624OPERACEPB SWISS TOOLS AGGXL2024-09-24
07610733850655OPERACEPB SWISS TOOLS AGGXL2024-09-24
07610733850693OPERACEPB SWISS TOOLS AGGXL2024-09-24
07610733850709OPERACEPB SWISS TOOLS AGGXL2024-09-24
07610733850716OPERACEPB SWISS TOOLS AGGXL2024-09-24
07610733851966OPERACEPB SWISS TOOLS AGGXL2024-09-24
06903195298570Disposable Screwdriver BladeKontour(Xi'An) Medical Technology Co.,Ltd.GXL2024-03-22
06903195298587Disposable Screwdriver BladeKontour(Xi'An) Medical Technology Co.,Ltd.GXL2024-03-22
04056481145606HEX SCREWDRIVER T-HANDLE (2.5 MM)Brainlab SEGXL2023-10-19
00888233048361SEEG LONG BOLT DRIVERBIOMET MICROFIXATION, INCGXL2023-06-07
00888233048378SEEG SHORT BOLT DRIVERBIOMET MICROFIXATION, INCGXL2023-06-07
00856482008467KLS E-Coupling AdapterPRO-DEX, INC.GXL2023-05-23
04056481144708Skull Reference Screwdriver HandleBrainlab SEGXL2023-05-05
04056481144715Skull Reference Screwdriver BladeBrainlab SEGXL2023-05-05
G28435301ScrewdriverNeurovention LLCGXL2022-06-21
00856482008252Pro-Dex CMF Surgical Driver (AXS™ NEURO DRIVER)PRO-DEX, INC.GXL2022-04-01
00856482008269MatrixPRO II Handpiece LoanerPRO-DEX, INC.GXL2022-04-01
00856482008283Battery Pack, Single Use, PDCMF, TadiranPRO-DEX, INC.GXL2022-04-01
00860540000225MatrixPRO Driver LoanerPRO-DEX, INC.GXL2022-04-01
00856482008122BATTERY PACK, KLS-SD-2000, SINGLEPRO-DEX, INC.GXL2022-03-29
00862377000140BATTERY PACK, KLS-SD-1000, SINGLEPRO-DEX, INC.GXL2022-03-29
00856482008016KLS E-Coupling AdapterPRO-DEX, INC.GXL2022-03-29
00856482008115KLS MaxDriver 2 PRO-DEX, INC.GXL2022-03-29