FDA.report

Stainless Steel Femoral Nailing System

Primary DI
18032568033748
Brand
Stainless Steel Femoral Nailing System
Company
ORTHOFIX SRL
Model
1
Catalog number
171130
Device description
FLEXIBLE REAMER D 13.0 MM
Published
2016-09-16
Public version status
Update
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
HSBRod, Fixation, Intramedullary And Accessories

Product Code Classifications

CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
18032568033748PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1803256803374818032568033748

GMDN Terms

TermDefinition
Medullary canal orthopaedic reamer, flexibleAn orthopaedic surgical instrument designed to open and enlarge the medullary canal (e.g., in the femur, tibia, ulnar) for the insertion of various devices during prosthesis implantation or fracture fixation procedures. It is typically designed as a long cylindrical device with straight, spiralled or contoured flutes acting as the cutting surfaces that is attached to a flexible shaft for manual or powered rotation. It is typically made of a high-grade stainless steel alloy; it comes in varying sizes. This is a reusable device.

Device Sizes

TypeValueUnit
Outer Diameter13Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+039456719000info@orthofix.it

Regulatory Flags

DUNS number
438793622
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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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