FDA.reportPublic FDA data

Surgical Instrument

Primary DI
08800089423880
Brand
Surgical Instrument
Company
Jeil Medical Corporation
Model
111-021
Published
2026-04-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HXZCutter, Wire

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXZCutter, WireOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800089423880PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800089423880088000894238808800089423880

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implantable-device cutterA heavy-duty manual surgical instrument designed to hold and cut orthopaedic surgical implant devices (i.e., metal rods, plates, screws). The cutting is typically performed with a shearing action. It may be a hand-held or a table mounted device. 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
08800089458875Leforte MMF System20-MS-0062026-04-09
08800089458882Leforte MMF System20-MS-0082026-04-09
08800089458899Leforte MMF System20-MS-0102026-04-09
08800089458905Leforte MMF System20-MS-0122026-04-09
08800089458912Leforte MMF System20L-MP-L132026-04-09
08800089458929Leforte MMF System20L-MP-U132026-04-09
08800089458936Leforte MMF System20L-MS-0062026-04-09
08800089458943Leforte MMF System20L-MS-0082026-04-09
08800089458950Leforte MMF System20L-MS-0102026-04-09
08800089458967Leforte MMF System20L-MS-0122026-04-09
08800089458974Leforte MMF System20L-MS-F062026-04-09
08800089458981Leforte MMF System20L-MS-F082026-04-09
08800089458998Leforte MMF System20L-MS-F102026-04-09
08800089459001Leforte MMF System20L-MS-F122026-04-09
08800089466801Surgical Instrument112-1942026-04-09
08800089476886Surgical Instrument111-5912026-04-09
08800089476893Surgical Instrument111-6362026-04-09
08806390880350ARIX Rib System Bone Plate24-CVRB-0042022-12-06
08806390880367ARIX Rib System Bone Plate24-CVRB-0062022-12-06
08806390880374ARIX Rib System Bone Plate24-CVRB-0082022-12-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20757770457766Bausch + LombBausch & Lomb IncorporatedHXZ2026-04-30
20757770457773Bausch + LombBausch & Lomb IncorporatedHXZ2026-04-30
20757770457780Bausch + LombBausch & Lomb IncorporatedHXZ2026-04-30
00810118108051NuSmile Hard Wire CutterNUSMILE, LTD.HXZ2026-04-08
00192896122994Table Top Rod CutterSONTEC INSTRUMENTS, INC.HXZ2026-03-31
00841506142364GeminusSKELETAL DYNAMICS L.L.C.HXZ2026-01-21
00192896122529Crimper/CutterSONTEC INSTRUMENTS, INC.HXZ2025-11-21
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