Trauma-Misc

FDA UDI

Class I (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name: Trauma-Misc FDA UDI
Generic Name: Manual surgical rotary handpiece, reusable FDA UDI
Device Name: HAND DRILL FDA UDI
Model / Reference: E0016955-1 FDA UDI
Description: HAND DRILL FDA UDI

Identifiers

Catalog Number: E0016955-1 FDA UDI
Primary DI / UDI-DI: 00885556783054 FDA UDI
FDA Product Code: HWE FDA UDI
GMDN Term: Manual surgical rotary handpiece, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4820 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: Manual surgical rotary handpiece, reusable

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

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HALLMARK — Orthofix US LLC · Class I
CHESAPEAKE Stabilization System — K2M, 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: Smith & Nephew, Inc.

Sources (1)

FDA UDI d7f3d378-49bc-4906-8178-21cc085ef79e 35 fields · synced Jun 8, 2026