FDA.report

Centronail Titanium Humeral Nailing System

Primary DI
18032568039719
Brand
Centronail Titanium Humeral Nailing System
Company
ORTHOFIX SRL
Model
1
Catalog number
99-178282
Device description
GUIDE WIRE WITHOUT OLIVE D.2.5X780 MM STERILE
Published
2015-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
JDSNail, Fixation, Bone

Product Code Classifications

CodeDeviceSpecialtyClass
JDSNail, Fixation, BoneOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
18032568039719PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1803256803971918032568039719

GMDN Terms

TermDefinition
Bone nail guidewire, reusableA long, thin, metal rod designed to guide intramedullary canal devices for performing the implantation of an intramedullary nail to treat damaged bone. The rod is usually manually inserted into the canal to typically guide a surgical instrument (e.g., a reamer) and the implantable nail. This device is made of metal [e.g., high-grade stainless steel, titanium (Ti)] and is available in a variety of sizes, lengths, and designs (e.g., round-tip, trocar-tip, or flexible-tip). It may be used in femoral, tibial, humeral or supracondylar intramedullary canals. This is a reusable device.

Device Sizes

TypeValueUnit
Length780Millimeter
Outer Diameter2.5Millimeter

Sterilization Methods

Method

Contacts

PhoneEmail
+039456719000info@orthofix.it

Regulatory Flags

DUNS number
438793622
Device count
1
DM exempt
false
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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