FDA.reportPublic FDA data

GIZA

Primary DI
07640167930111
Brand
GIZA
Company
Eden Spine Europe SA
Model
Giza Torx 8 screwdriver L 250 mm
Catalog number
48293125
Device description
Orthopaedic manual surgical instrument.
Published
2018-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
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
07640167930111PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640167930111076401679301117640167930111

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant/instrument assembling deviceA non-sterile, noninvasive tool designed to support assembly of the component parts of an orthopaedic implant or surgical instrument during an orthopaedic surgical procedure, typically when component sizes are determined during the procedure [e.g., stem, neck, and head femoral components of a total hip arthroplasty (THA)]. It is available in one of a variety of forms (e.g., holder, clamp/press), however it is not a component of the final instrument/implant and is not a surgical screwdriver or wrench. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
482797425
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640167930180GIZAGiza Instruments tray lid482934012018-09-24
07640167930197GIZAGiza Instruments tray with silicone inserts482934002018-09-24
07640167930456GIZAGiza Instruments tray lid1009W2018-09-24
07640167930463GIZAGiza Instruments tray with silicone inserts1009V2018-09-24
07640167930074GIZAGiza- Holder distractor Lg 220 mm482932202018-09-24
07640167930081GIZAGiza- Holder distractor Lg 320 mm482933202018-09-24
07640167930098GIZAGiza Removable holder distractor tip Ø 14 mm482930142018-09-24
07640167930159GIZAGiza Implant holding block482934042018-09-24
07640167930326GIZAGiza- Holder distractor Lg 220 mm100232018-09-24
07640167930333GIZAGiza- Holder distractor Lg 320 mm1009U2018-09-24
07640167930340GIZAGiza Removable holder distractor tip Ø 14 mm100242018-09-24
07640167930357GIZAGiza Removable holder distractor tip Ø 21 mm100252018-09-24
07640167930364GIZAGiza Removable holder distractor tip Ø 27 mm100262018-09-24
07640167930425GIZAGiza Implant holding block1009Y2018-09-24
07640167930012GIZACorpectomy implant Giza, Diam 14 mm, 18-22 mm, 2-548291482S2015-09-24
07640167930029GIZACorpectomy implant Giza, Diam 14 mm, 18-22 mm, 5-848291485S2015-09-24
07640167930036GIZACorpectomy implant Giza, Diam 14 mm, 23-32 mm, 2-548291422S2015-09-24
07640167930043GIZACorpectomy implant Giza, Diam 14 mm, 23-32 mm, 7-148291427S2015-09-24
07640167930050GIZACorpectomy implant Giza, Diam 14 mm, 33-54 mm, 2-548291432S2015-09-24
07640167930067GIZACorpectomy implant Giza, Diam 14 mm, 33-54 mm, 7-148291437S2015-09-24

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