Ectra

FDA UDI

Class II (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name: ECTRA FDA UDI
Generic Name: Rigid optical arthroscope, reusable FDA UDI
Device Name: ECTRA II CARPAL LIGAMENT SYSTEM, DIRECT-VIEW, 4.0 MM, 30 DEGREE, 100 DEGREE WORKING LENGTH, SAME SIDE CANNULA CONNECTION SERVICE REPLACEMENT FDA UDI
Model / Reference: 4144S FDA UDI
Description: ECTRA II CARPAL LIGAMENT SYSTEM, DIRECT-VIEW, 4.0 MM, 30 DEGREE, 100 DEGREE WORKING LENGTH, SAME SIDE CANNULA CONNECTION SERVICE REPLACEMENT FDA UDI

Identifiers

Catalog Number: 4144S FDA UDI
Primary DI / UDI-DI: 03596010122629 FDA UDI
FDA Product Code: HRX FDA UDI
GMDN Term: Rigid optical arthroscope, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.1100 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

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Hydrogen Peroxide FDA UDI

Category: Rigid optical arthroscope, reusable

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

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Also classified as Rigid optical arthroscope, reusable.

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Olympus — Olympus Winter & Ibe GmbH · Class II
Surgical Direct — SURGICAL DIRECT, INC. · Class II
HOPKINS — Karl Storz GmbH & Co. KG · Class II
Precision Ideal Eyes — Stryker Corp. · 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 II	Pending data

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Manufacturer

Manufacturer: Smith & Nephew, Inc.

Sources (1)

FDA UDI 02b6f9ff-8455-47ea-a3fc-2a1c2c4ec20f 35 fields · synced Jun 8, 2026