FDA.report

NEONAIL

Primary DI
07899893220441
Brand
NEONAIL
Company
Neoortho Produtos Ortopédicos S/A.
Model
930.071
Device description
Internal Fracture Alignment Device
Published
2023-11-23
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
FZXGuide, Surgical, Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07899893220441PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07899893220441078998932204417899893220441

GMDN Terms

TermDefinition
Orthopaedic bone-fragment manipulator, reusableA hand-held manual surgical instrument designed to help position a fractured fragment of bone to achieve proper alignment (reduction). It is typically a long, thin, rigid rod made of high-grade stainless steel with a self-drilling/self-tapping screw thread at the distal end and a connector at the proximal end to attach an appropriate handle. The device is usually inserted transcutaneously to the fractured section of bone (e.g., through the skin and into a craniofacial fracture) and removed after positioning and fixation of the fracture. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+554135351000sac@neoortho.com.br

Regulatory Flags

DUNS number
914644351
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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
07899893220120NEOORTHO908.132908.1322025-04-23
07899893220137NEOORTHO908.143908.1432024-05-16
07898624860017NEOFIX900.0012015-10-15
07898624860024NEOFIX900.0052015-10-15
07898624860031NEOFIX900.0022015-10-15
07898624860048NEOFIX900.0032015-10-15
07898624860055NEOFIX901.0272015-09-25
07898624860062NEOFIX900.0042015-10-15
07898624860079NEOFIX900.0062015-10-15
07898624860086NEOFIX900.0072015-10-15
07898624860093NEOFIX901.0282015-09-25
07898624860109NEOFIX901.0292015-09-25
07898624860116NEOFIX901.0302015-09-25
07898624860123NEOFIX900.0092015-10-15
07898624860130NEOFIX900.0102015-10-15
07898624860147NEOFIX900.0112015-10-15
07898624860154NEOFIX900.0122015-10-15
07898624860161NEOFIX900.0132015-10-15
07898624860178NEOFIX900.0142015-10-15
07898624860185NEOFIX900.1012015-10-15

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