FDA.report

Centronail Titanium Humeral Nailing System

Primary DI
18032937168248
Brand
Centronail Titanium Humeral Nailing System
Company
ORTHOFIX SRL
Model
1
Catalog number
99-T788230
Device description
CENTRONAIL TITANIUM HUMERAL NAIL D.8 MM-L.230 MM
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
18032937168248PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1803293716824818032937168248

GMDN Terms

TermDefinition
Orthopaedic bone screw, non-bioabsorbable, sterileA small, sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). There are a number of kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression across bone fragments.

Device Sizes

TypeValueUnit
Length230Millimeter
Outer Diameter8Millimeter

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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