FDA.report

Orthopaedic Surgical Instruments

Primary DI
08032909627967
Brand
Orthopaedic Surgical Instruments
Company
CITIEFFE SRL
Model
Universal nail extractor
Catalog number
GH5105
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
HWBExtractor

Product Code Classifications

CodeDeviceSpecialtyClass
HWBExtractorOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08032909627967PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08032909627967080329096279678032909627967

GMDN Terms

TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a reusable device.

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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