FDA.report

Fixion Nailing System

Primary DI
07290109330068
Brand
Fixion Nailing System
Company
CARBOFIX ORTHOPEDICS LTD
Model
Humeral Nail
Catalog number
1110030
Device description
The nail is intended for use in the fixation of long bone fractures, including diaphyseal fractures. It is indicated for shaft fractures 5cm below the
Published
2015-10-19
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
07290109330068PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07290109330068072901093300687290109330068

GMDN Terms

TermDefinition
Humerus nail, sterileA sterile rod made of metal or other material which, when inserted into the intramedullary canal of the humerus, acts to immobilize by holding the ends of a fractured bone in position to promote healing. The device may also be used to support the bone in the presence of a pathological condition. The device may be a locked or unlocked model, and possess components to assist fixation of more proximal or distal conditions. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Length300Millimeter

Sterilization Methods

Method

Contacts

PhoneEmail
1-800-408-0120usa@carbo-fix.com

Regulatory Flags

DUNS number
649185170
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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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