FDA.reportPublic FDA data

Guide Wire

Primary DI
09120047299494
Brand
Guide Wire
Company
I.T.S. GmbH
Model
35124-180
Catalog number
35124-180
Device description
Guide Wire, Steel, D=1.2mm, L=180mm, TR, w. Thrd.
Published
2018-11-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
09120047299494PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09120047299494091200472994949120047299494

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic guidewire, reusableA thin, non-implantable rod designed to guide the insertion of a cannulated orthopaedic implant (typically an intramedullary nail or screw) and/or surgical instrument (e.g., drill bit) during an orthopaedic procedure. It is made of metal and is available in a variety of sizes, lengths, and designs (e.g., round-tip, trocar-tip, or flexible-tip). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
303456917
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Sterilization required before use
true

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09120034300417Bending Iron66252-1466252-142018-11-08
09120034306419Small Plate Bending Iron KM 47-915KM 47-9152018-11-13
09120034306426Small Plate Bending Iron KM 47-916KM 47-9162018-11-13
09120047301883Bending HeaverKJ.206.14KJ.206.142018-11-14
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09120069815429In-Situ Bending Iron66261662612018-11-08
09120069815436In-Situ Bending Iron66262662622018-11-08
09120069815443In-Situ Bending Iron66263662632018-11-08
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09120034302633Fibula Plate PROlock21222-621222-62016-09-08
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