Trauma - Misc

FDA UDI

Class I (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name: TRAUMA - MISC FDA UDI
Generic Name: Dental reinforcing fibre FDA UDI
Device Name: MODIFIED BLOCKING SCREW GUIDE FDA UDI
Model / Reference: E0016368-1 FDA UDI
Description: MODIFIED BLOCKING SCREW GUIDE FDA UDI

Identifiers

Catalog Number: E0016368-1 FDA UDI
Primary DI / UDI-DI: 00885556739181 FDA UDI
FDA Product Code: FZX FDA UDI
GMDN Term: Dental reinforcing fibre 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

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Dental reinforcing fibre

Trauma - Misc by Smith & Nephew, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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everStick® — Gc America Inc. · Class II
Dentapreg® INTRO — ADM, a.s. · 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 I	Pending data

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Manufacturer

Manufacturer: Smith & Nephew, Inc.

Sources (1)

FDA UDI e6da0bda-a99f-415c-b777-5ff9244f363b 35 fields · synced Jun 8, 2026