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Trigen

FDA UDI

Class II (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name
Trigen FDA UDI
Generic Name
Orthopaedic stereotactic surgery system FDA UDI
Device Name
LONG HEXDRIVER FDA UDI
Model / Reference
E0015944-1 FDA UDI
Description
LONG HEXDRIVER FDA UDI

Identifiers

Catalog Number
E0015944-1 FDA UDI
Primary DI / UDI-DI
00885556715147 FDA UDI
510(k) Number
K100107 FDA UDI
K122170 FDA UDI
FDA Product Code
HSB FDA UDI
OLO FDA UDI
GMDN Term
Orthopaedic stereotactic surgery system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3020 FDA UDI
882.4560 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Surgical screwdriver, reusableOrthopaedic stereotactic surgery system

Trigen by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic stereotactic surgery system.

Cleared under the same submission

K100107 also covers:

K122170 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Smith & Nephew, Inc.

Sources (1)

  • FDA UDI 0c08dfbd-1b72-4595-8c50-c14c10c9a09a 36 fields · synced Jun 8, 2026