Tools - WFS

FDA UDI

Class II (US FDA UDI)

by Trimed, INC.

Identity

Trade Name: Tools - WFS FDA UDI
Generic Name: Instrument tray, reusable FDA UDI
Device Name: WS3, Gauge Bracket FDA UDI
Model / Reference: GAUGE-BRKT FDA UDI
Description: WS3, Gauge Bracket FDA UDI

Identifiers

Catalog Number: GAUGE-BRKT FDA UDI
Primary DI / UDI-DI: 00842188128226 FDA UDI
510(k) Number: K243569 FDA UDI
FDA Product Code: KCT FDA UDI
GMDN Term: Instrument tray, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.6850 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

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: Instrument tray, reusable

Tools - WFS by Trimed, INC. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Instrument tray, reusable.

MİKRO — SAMSUN MİKRO CERRAHİ ALETLER İMALAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ · Class I
Hu-Friedy — Hu-Friedy Manufacturing Co., LLC · Class I
Instrument Case — Katena Products, Inc. · Class I
Hu-Friedy — Hu-Friedy Manufacturing Co., LLC · Class I
MİKRO — SAMSUN MİKRO CERRAHİ ALETLER İMALAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ · Class I
SHEFFIELD RING FIXATOR — Orthofix, Inc. · Class II
MİKRO — SAMSUN MİKRO CERRAHİ ALETLER İMALAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ · Class I
ASELTECH — Asel Tibbi Aletler A.S. · Class I

Cleared under the same submission

K243569 also covers:

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

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

Manufacturer

Manufacturer: Trimed, INC.

Sources (1)

FDA UDI 28981870-42b1-4541-b809-c5b7921b964e 36 fields · synced May 30, 2026