FDA.report

Surgical Instrument

Primary DI
08809265158899
Brand
Surgical Instrument
Company
Jeil Medical Corporation
Model
111-034
Published
2018-09-06
Public version status
Update
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

Product Codes

CodeName
HXZCutter, Wire

Product Code Classifications

CodeDeviceSpecialtyClass
HXZCutter, WireOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08809265158899PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08809265158899088092651588998809265158899

GMDN Terms

TermDefinition
Bone fixation plate pliersA manual surgical instrument designed to bend and cut light-bone fixation plates (e.g., 1 to 2 mm in thickness), such as those used in craniomaxillofacial (CMF) or finger surgery. The instrument is typically made of high-grade steel and consists of two arms/rods that form a handle proximally and extend distally through a pivot to form jaws that bend and cut the metal plates allowing the surgeon to customize their size and shape. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
688811603
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
08800089480128Summa Orthopaedics Femur Nail SystemSO-SPFL-A0702026-02-23
08800089480135Summa Orthopaedics Femur Nail SystemSO-SPFL-A0752026-02-23
08800089480142Summa Orthopaedics Femur Nail SystemSO-SPFL-A0802026-02-23
08800089480159Summa Orthopaedics Femur Nail SystemSO-SPFL-A0852026-02-23
08800089480166Summa Orthopaedics Femur Nail SystemSO-SPFL-A0902026-02-23
08800089480173Summa Orthopaedics Femur Nail SystemSO-SPFL-A0952026-02-23
08800089480180Summa Orthopaedics Femur Nail SystemSO-SPFL-A1002026-02-23
08800089480197Summa Orthopaedics Femur Nail SystemSO-SPFL-A1052026-02-23
08800089480203Summa Orthopaedics Femur Nail SystemSO-SPFL-A1102026-02-23
08800089480210Summa Orthopaedics Femur Nail SystemSO-SPFL-A1152026-02-23
08800089480227Summa Orthopaedics Femur Nail SystemSO-SPFL-A1202026-02-23
08800089480234Summa Orthopaedics Femur Nail SystemSO-SPFL-A1252026-02-23
08800089480241Summa Orthopaedics Femur Nail SystemSO-SPFL-A1302026-02-23
08800089480258Summa Orthopaedics Femur Nail SystemSO-SPFL-T0852026-02-23
08800089480265Summa Orthopaedics Femur Nail SystemSO-SPFL-T0902026-02-23
08800089480272Summa Orthopaedics Femur Nail SystemSO-SPFL-T0952026-02-23
08800089480289Summa Orthopaedics Femur Nail SystemSO-SPFL-T1002026-02-23
08800089480296Summa Orthopaedics Femur Nail SystemSO-SPFL-T1052026-02-23
08800089480302Summa Orthopaedics Femur Nail SystemSO-SPFL-T1102026-02-23
08800089480319Summa Orthopaedics Femur Nail SystemSO-SPFL-T1152026-02-23

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00841506142364GeminusSKELETAL DYNAMICS L.L.C.HXZ2026-01-21
00199150050888Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXZ2025-11-20
D90980001641ORTHO ARCHOrtho Arch Company IncHXZ2025-09-15
D90980001651ORTHO ARCHOrtho Arch Company IncHXZ2025-09-15
D9098000331SPECTRUMOrtho Arch Company IncHXZ2025-09-15
D90980021311RAZOROrtho Arch Company IncHXZ2025-09-15
D90980021412RAZOROrtho Arch Company IncHXZ2025-09-15
D90980021513RAZOROrtho Arch Company IncHXZ2025-09-15
D90980021715RAZOROrtho Arch Company IncHXZ2025-09-15
D90980021816RAZOROrtho Arch Company IncHXZ2025-09-15
D90980021917RAZOROrtho Arch Company IncHXZ2025-09-15
D90980022312RAZOROrtho Arch Company IncHXZ2025-09-15
00841435124912TecometTECOMET INC.HXZ2025-09-05
00190776409432MillenniumAvalign Technologies, Inc.HXZ2025-09-02
10818674026298Knotless flush cutterT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHXZ2025-08-12
10818674025994Multi Suture CutterT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHXZ2025-08-11
00190776407766MillenniumAvalign Technologies, Inc.HXZ2025-08-01
00194613013912MSI Precision Specialty InstrumentsMed Saver, Inc.HXZ2025-08-01
00194613013929MSI Precision Specialty InstrumentsMed Saver, Inc.HXZ2025-08-01
00194613013936MSI Precision Specialty InstrumentsMed Saver, Inc.HXZ2025-08-01
00194613013943MSI Precision Specialty InstrumentsMed Saver, Inc.HXZ2025-08-01
00194613013950MSI Precision Specialty InstrumentsMed Saver, Inc.HXZ2025-08-01
00194613015893MSI Precision Specialty InstrumentsMed Saver, Inc.HXZ2025-08-01
00194613015909MSI Precision Specialty InstrumentsMed Saver, Inc.HXZ2025-08-01
00194613021979MSI Precision Specialty InstrumentsMed Saver, Inc.HXZ2025-08-01
00194613059187MSI Precision Specialty InstrumentsMed Saver, Inc.HXZ2025-08-01
00194613088323MSI Precision Specialty InstrumentsMed Saver, Inc.HXZ2025-08-01
00194613089979MSI Precision Specialty InstrumentsMed Saver, Inc.HXZ2025-08-01
00194613093549MSI Precision Specialty InstrumentsMed Saver, Inc.HXZ2025-08-01
00194613093556MSI Precision Specialty InstrumentsMed Saver, Inc.HXZ2025-08-01