FDA.reportPublic FDA data

ILIZAROV SYSTEMS

Primary DI
08033201842065
Brand
ILIZAROV SYSTEMS
Company
MEDICALPLASTIC SRL
Model
103101
Catalog number
103101
Device description
DYNAMOMETRIC WIRE TENSIONER
Published
2016-09-30
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
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
08033201842065PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08033201842065080332018420658033201842065

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
434581062
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
28033201846890ILIZAROV SYSTEMS1021011021012025-08-20
28033201846906ILIZAROV SYSTEMS1021021021022025-08-20
28033201846913ILIZAROV SYSTEMS1021061021062025-08-20
28033201846920ILIZAROV SYSTEMS1021071021072025-08-20
08033201841716ILIZAROV SYSTEMS1021011021012025-08-20
08033201841723ILIZAROV SYSTEMS1021021021022025-08-20
08033201841754ILIZAROV SYSTEMS1021061021062025-08-20
08033201841761ILIZAROV SYSTEMS1021071021072025-08-20
08033201842416ILIZAROV SYSTEMS71012502710125022016-11-01
28033201841710ILIZAROV SYSTEMS1021011021012016-10-27
28033201841727ILIZAROV SYSTEMS 1021021021022016-10-27
28033201841765ILIZAROV SYSTEMS1021071021072016-10-27
08033201840795ILIZAROV SYSTEMS1001101001102016-10-07
08033201840801ILIZAROV SYSTEMS1001111001112016-10-07
08033201840818ILIZAROV SYSTEMS1001121001122016-10-07
08033201840993ILIZAROV SYSTEMS1006001006002016-09-30
08033201841006ILIZAROV SYSTEMS1006011006012016-09-30
08033201841013ILIZAROV SYSTEMS1007001007002016-09-30
08033201842324ILIZAROV SYSTEMS71013000710130002016-09-30
08033201842331ILIZAROV SYSTEMS71013002710130022016-09-30

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Primary DI, Brand, Company table
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