Isolyser/SMS

FDA UDI

Class II (US FDA UDI)

by Wcm Waste & Compliance Management, Inc.

Identity

Trade Name: Isolyser/SMS FDA UDI
Generic Name: Sharps container FDA UDI
Device Name: 10.47 liters sharps container pre-filled with a liquid monomer. Simply fill with sharps (needles, blades, endo files, empty carpules and any other potential sharps), when full, the ‘catalyst’ packs are added causing the liquid to heat and convert into solid plastic polymer, safely encapsulating and rendering the sharps unusable and non-recognizable; making them safe for the regular trash, if acceptable under state and local regulations. FDA UDI
Model / Reference: SMS10000 FDA UDI
Description: 10.47 liters sharps container pre-filled with a liquid monomer. Simply fill with sharps (needles, blades, endo files, empty carpules and any other potential sharps), when full, the ‘catalyst’ packs are added causing the liquid to heat and convert into solid plastic polymer, safely encapsulating and rendering the sharps unusable and non-recognizable; making them safe for the regular trash, if acceptable under state and local regulations. FDA UDI

Identifiers

Catalog Number: SMS10000 FDA UDI
Primary DI / UDI-DI: 00858629005032 FDA UDI
510(k) Number: K090156 FDA UDI
FDA Product Code: FMI FDA UDI
GMDN Term: Sharps container FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5570 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

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

Category: Sharps container

Isolyser/SMS by Wcm Waste & Compliance Management, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Sharps container.

SharpSafety — Cardinalhealth · Class II
Henry Schein — HENRY SCHEIN, INC. · Class II
AUVON — Shenzhen Yuwen E-Commerce Co., Ltd. · Class II
SharpSafety — Cardinalhealth · Class II
SharpsTank — REHRIG PACIFIC COMPANY · Class II
BD Sharps Collector — BECTON DICKINSON AND COMPANY · Class II
Stericycle Reusable Sharps Container — Stericycle, Inc. · Class II
Daniels — DANIELS CORPORATION INTERNATIONAL PTY LTD · Class II

Cleared under the same submission

K090156 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

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Manufacturer

Manufacturer: Wcm Waste & Compliance Management, Inc.

Sources (1)

FDA UDI cd12c769-8447-42a0-bf8a-e3a8f203d72f 35 fields · synced Jun 1, 2026