Surfix®

FDA UDI

Class I (US FDA UDI)

by Newdeal Sas

Identity

Trade Name: SURFIX® FDA UDI
Generic Name: Surgical drill guide, reusable FDA UDI
Device Name: The drilling guide is placed in the plate on the bone and is used to guide the drilling of the bone and protect the soft tissues. FDA UDI
Model / Reference: MA007ND FDA UDI
Description: The drilling guide is placed in the plate on the bone and is used to guide the drilling of the bone and protect the soft tissues. FDA UDI

Identifiers

Primary DI / UDI-DI: 10381780045656 FDA UDI
FDA Product Code: HTW FDA UDI
GMDN Term: Surgical drill guide, reusable 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

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

Category: Surgical drill guide, reusable

Surfix® by Newdeal Sas — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical drill guide, reusable.

ORTHOFIX — Orthofix, Inc. · Class I
Titan™ — Ascension Orthopedics, Inc. · Class I
Medtronic Resuable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
Distal Elbow Plating System — SKELETAL DYNAMICS L.L.C. · Class II
Truliant — Exactech, Inc. · Class II
Vantage — Exactech, Inc. · Class II
Legion — Smith & Nephew, Inc. · Class II
Hintermann Series — Dt Medtech, LLC · 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

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

Manufacturer

Manufacturer: Newdeal Sas

Sources (1)

FDA UDI d933007f-5bd2-4d99-a40b-2e4c52586ff1 36 fields · synced May 30, 2026