Forefoot Solutions™

FDA UDI

Class I (US FDA UDI)

by Newdeal Sas

Identity

Trade Name: FOREFOOT SOLUTIONS™ FDA UDI
Generic Name: Orthopaedic reamer guide FDA UDI
Device Name: FF2 TRANSVERSAL CUTTING GUIDE - The transversal cutting guide is used to guide the saw blade during bone resection. It has a slot of 0.8mm width and 13mm length in which the saw blade is inserted. FDA UDI
Model / Reference: 229012ND FDA UDI
Description: FF2 TRANSVERSAL CUTTING GUIDE - The transversal cutting guide is used to guide the saw blade during bone resection. It has a slot of 0.8mm width and 13mm length in which the saw blade is inserted. FDA UDI

Identifiers

Catalog Number: 229012ND FDA UDI
Primary DI / UDI-DI: 10381780043119 FDA UDI
FDA Product Code: FZX FDA UDI
GMDN Term: Orthopaedic reamer guide FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Length — 15 Millimeter FDA UDI
Width — 11 Millimeter FDA UDI

Category: Orthopaedic reamer guide

Forefoot Solutions™ by Newdeal Sas — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Titan Reverse Shoulder System — Smith & Nephew, Inc. · Class I
MAXIM RESECTION DISTAL — Biomet Orthopedics, Inc. · Class I
Arthrex® — Arthrex, Inc. · Class I

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 I	Pending data

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Manufacturer

Manufacturer: Newdeal Sas

Sources (1)

FDA UDI 5efd8d68-ab72-436f-830d-9155605cfd9c 37 fields · synced Jun 1, 2026