Forefoot Solutions™

FDA UDI

Class I (US FDA UDI)

by Newdeal Sas

Identity

Trade Name: FOREFOOT SOLUTIONS™ FDA UDI
Generic Name: Fluted surgical drill bit, single-use FDA UDI
Device Name: Non-sterile '2 in 1' shouldered drill to single drive the body of compression screws and shape of the screw heads to allow complete countersink FDA UDI
Model / Reference: 119015ND FDA UDI
Description: Non-sterile '2 in 1' shouldered drill to single drive the body of compression screws and shape of the screw heads to allow complete countersink FDA UDI

Identifiers

Catalog Number: 119015 FDA UDI
Primary DI / UDI-DI: 10381780045175 FDA UDI
FDA Product Code: HTW FDA UDI
GMDN Term: Fluted surgical drill bit, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

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 — 90 Millimeter FDA UDI

Category: Fluted surgical drill bit, single-use

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

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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 c7fe16db-af2a-4012-afaa-d03d3573e68f 38 fields · synced Jun 1, 2026