FDA.reportPublic FDA data

Surgical Instrument

Primary DI
08809282812828
Brand
Surgical Instrument
Company
Jeil Medical Corporation
Model
111-026-3-L
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
KTETrocar, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KTETrocar, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809282812828PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809282812828088092828128288809282812828

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implantation sleeve, reusableA hand-held tubular surgical device designed to be used during an orthopaedic implantation procedure to hold/grip an implant (e.g., an orthopaedic bone screw), facilitate the acceptance of an orthopaedic instrument (e.g., a screwdriver or a smaller diameter sleeve) through it, stabilize an instrument/implant coupling, and/or protect the surgeon's gloved hand or patient tissue. It is not primarily intended to place, angle, and guide a rotating surgical drill. It is typically made of high-grade stainless steel and/or synthetic materials and is available in various sizes and lengths. 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
05055445930615SurtexSURTEX INSTRUMENTS LTD.KTE2026-05-12
05055445930622SurtexSURTEX INSTRUMENTS LTD.KTE2026-05-12
05055445930639SurtexSURTEX INSTRUMENTS LTD.KTE2026-05-12
05055445930646SurtexSURTEX INSTRUMENTS LTD.KTE2026-05-12
05055445930653SurtexSURTEX INSTRUMENTS LTD.KTE2026-05-12
05055445930660SurtexSURTEX INSTRUMENTS LTD.KTE2026-05-12
04046826472153MediconMedicon eG. Chirurgiemechaniker-GenossenschaftKTE2025-12-17
04250381812860Antrum trocar, oblique beakSpiggle & Theis Medizintechnik GmbHKTE2025-10-05
04250381812846Antrum trocar, beakedSpiggle & Theis Medizintechnik GmbHKTE2025-09-10
04250381812853Antrum trocar, oblique beakSpiggle & Theis Medizintechnik GmbHKTE2025-09-10
04250381812877Antrum trocar, oblique beakSpiggle & Theis Medizintechnik GmbHKTE2025-09-10
00757770422029Bausch + LombBausch & Lomb IncorporatedKTE2024-11-21
00887482053300Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.KTE2024-08-15
10381780540120MicroFrance®INTEGRA MICROFRANCEKTE2024-05-29
10381780538530MicroFrance®INTEGRA MICROFRANCEKTE2024-05-29
00381780105872MicroFrance®INTEGRA MICROFRANCEKTE2024-05-29
14026704912053PILLINGTELEFLEX INCORPORATEDKTE2024-05-24
24026704912050PILLINGTELEFLEX INCORPORATEDKTE2024-05-24
00888515242265BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KTE2024-02-28
00888515242272BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KTE2024-02-28
00888515243262BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KTE2024-02-28
00888515243279BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KTE2024-02-28
G586E1063390Novo SurgicalNOVO SURGICAL, INC.KTE2023-12-18
07899893232154NEONAILNeoortho Produtos Ortopédicos S/A.KTE2023-11-29
00190776378455MillenniumAvalign Technologies, Inc.KTE2023-11-13
00190776322687MILLENNIUMAvalign Technologies, Inc.KTE2023-09-28
00190776375201MILLENNIUMAvalign Technologies, Inc.KTE2023-09-28
14026704809278PILLINGTELEFLEX INCORPORATEDKTE2022-12-08
54026704809276PILLINGTELEFLEX INCORPORATEDKTE2022-12-08
00842331163500Novo Surgical Inc. NOVO SURGICAL, INC.KTE2022-11-13