FDA.reportPublic FDA data

Orthopaedic Surgical Instruments

Primary DI
00805671192807
Brand
Orthopaedic Surgical Instruments
Company
CITIEFFE SRL
Model
Reamers tray
Catalog number
5110-000
Published
2022-06-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00805671192807PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00805671192807008056711928078056711928070805671192807

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing clinical instruments (typically endoscopes or surgical instruments) for use during a clinical procedure; it might in addition be used during, but not dedicated to, reprocessing/sterilization procedures. It is typically in the form of a shallow vessel with a raised rim, a deeper cassette-like device, or a flat or angled surface; it might include a lid. It may be designed to fit into other devices such as supply trolleys, storage systems and sterilizers, or designed to attach to a surgical/treatment table where it may be placed over the patient. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Dry and clean environment and avoid damaging the packing. Room temperature.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+39051721850info@citieffe.com

Regulatory Flags#

DUNS number
431406875
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
08059386748701Orthopaedic Surgical InstrumentsEntry reamer head ø8.5mm, hole ø2.7mm5112-0852026-05-27
08059386748718ORTHOPAEDIC MANUAL SURGICAL INSTRUMENTSHandle for scalpel ø7x200mm STERILE40462026-05-26
08059386748725ORTHOPAEDIC MANUAL SURGICAL INSTRUMENTSHandle for scalpel ø8x400mm STERILE40472026-05-26
08032909626380ST.A.R. 90 F4Pin and rod clamp kitF4-52202026-03-17
08059386742440Orthopaedic Manual Surgical InstrumentsSpanner 9-11mmSF10192026-03-17
08059386744369RONDO'Ruler for Rondo' screws ø3-4-5mmVP-920212026-03-17
08059386748244RONDO'Rondo' screws ø3-4-5mm instrument tray, emptyFN9101022026-03-17
08059386748251Orthopaedic Manual Surgical InstrumentsDiapason hammer gr.300382672026-03-17
08059386748237Orthopaedic Surgical InstrumentsWire tensionerSF6470P2026-03-16
08051739535730ST.A.R. 90 F4Knee fixator distractorF4-27462026-03-10
08059386748176ORTHOPAEDIC MANUAL SURGICAL INSTRUMENTSScrews ruler kit with drill bit, ø2.5x150mmDT0720342026-02-10
08059386748183ORTHOPAEDIC MANUAL SURGICAL INSTRUMENTSScrew ruler for drill bit L.150mmDT0720352026-02-10
08059386748190ORTHOPAEDIC MANUAL SURGICAL INSTRUMENTSNails ruler kit with wire ø2x600mmDT0720332026-02-10
08052990971299Orthopaedic Surgical InstrumentsQuick-connect adapter for screw ø4mmSF13042018-12-15
08052990971305Orthopaedic Surgical InstrumentsQuick-connect adapter for screw ø5mmSF13052018-12-15
08052990971312Orthopaedic Surgical InstrumentsQuick-connect adapter for screw ø6mmSF13062018-12-15
08059386742280Orthopaedic Surgical InstrumentsImpactor/extractor guideFN9000802025-11-05
08059386742518ESTREMO FIBULAR NAILEstremo Fibular Nail end cap, standardFN0000012025-12-15
08059386742525ESTREMO FIBULAR NAILEstremo Fibular Nail end cap, 2.5mmFN0000022025-12-15
08059386742532ESTREMO FIBULAR NAILEstremo Fibular Nail end cap, 5mmFN0000052025-12-15

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