FDA.reportPublic FDA data

Surgical Instrument

Primary DI
08800089466931
Brand
Surgical Instrument
Company
Jeil Medical Corporation
Model
111-597
Published
2025-06-15
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
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800089466931PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800089466931088000894669318800089466931

GMDN Terms#

Term, Definition table
TermDefinition
External orthopaedic fixation system, reusableAn assembly of devices designed to stabilize fractured bones, other than those in the vertebral column, to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, cams, bushings, collars, bolts and nuts; it may also include some instrumentation (e.g., screw drivers, wrenches, drills). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the wrist, elbow, knee, hip and ankle, joint fusions, and limb lengthening. 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
08800089423880Surgical Instrument111-0212026-04-09
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

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Primary DI, Brand, Company table
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