FDA.report

Orthopaedic Surgical Instruments

Primary DI
08032909622009
Brand
Orthopaedic Surgical Instruments
Company
CITIEFFE SRL
Model
Fracture alignment guide wire exchange tool
Catalog number
DT010020
Published
2021-11-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08032909622009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08032909622009080329096220098032909622009

GMDN Terms

TermDefinition
Orthopaedic bone-fragment manipulator, single-use, non-sterileA non-sterile, hand-held manual surgical instrument designed to help position a fractured fragment of bone to achieve proper alignment (reduction). It is typically a long, thin, rigid rod made of high-grade stainless steel with a self-drilling/self-tapping screw thread at the distal end and a connector at the proximal end to attach an appropriate handle. The device is usually inserted transcutaneously to the fractured section of bone (e.g., through the cheek and into the mandible) and removed after positioning and fixation of the fracture. This is a single-use device intended to be sterilized prior to use.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+39051721850info@citieffe.com

Regulatory Flags

DUNS number
431406875
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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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
08059386742280Orthopaedic Surgical InstrumentsImpactor/extractor guideFN9000802025-11-05
08059386742150ESTREMO FIBULAR NAILEstremo Fibular Nail guideFN9000102025-12-19
08059386742167ESTREMO FIBULAR NAILEstremo Fibular Nail 180 and 250mm proximal guideFN9000122025-12-19
08059386742174ESTREMO FIBULAR NAILNail connection screwFN9000132025-12-19
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
08059386742549ESTREMO FIBULAR NAILEstremo Fibular Nail ø3.3x130mm LeftFN03313L2025-12-15
08059386742556ESTREMO FIBULAR NAILEstremo Fibular Nail ø3.3x130mm RightFN03313R2025-12-15
08059386742563ESTREMO FIBULAR NAILEstremo Fibular Nail ø3.3x180mm LeftFN03318L2025-12-15

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