Neonail

FDA UDI

Class II (US FDA UDI)

by Neoortho Produtos Ortopédicos S/A.

Identity

Trade Name: NEONAIL FDA UDI
Generic Name: Femur intramedullary nail FDA UDI
Device Name: Right Long Femoral Trochanteric Nail D11x125x280 mm FDA UDI
Model / Reference: 931.100 FDA UDI
Description: Right Long Femoral Trochanteric Nail D11x125x280 mm FDA UDI

Identifiers

Primary DI / UDI-DI: 07899893232796 FDA UDI
FDA Product Code: HSB FDA UDI
GMDN Term: Femur intramedullary nail FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3020 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Femur intramedullary nail

Neonail by Neoortho Produtos Ortopédicos S/A. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Femur intramedullary nail.

GAMMA — Stryker Corp. · Class II
A.R.T.™FEMORAL NAIL — Biomet Orthopedics, Inc. · Class II
T2 ALPHA — Stryker Corp. · Class II
PRECICE® Bone Transport System — NuVasive Specialized Orthopedics, Inc. · Class II
T2 — Stryker Corp. · Class II
130° Ga-mma Nail — Auxein Medical Private Limited · Class II
ARIX Femur Nail System — Jeil Medical Corporation · Class II
INTERTAN — Smith & Nephew, Inc. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Neoortho Produtos Ortopédicos S/A.

Sources (1)

FDA UDI 835d9a31-3af3-43e7-a36d-3b45e52c4d10 34 fields · synced May 31, 2026