Sharps

FDA UDI

Class II (US FDA UDI)

by Pureway Compliance, Inc.

Identity

Trade Name: Sharps FDA UDI
Generic Name: Sharps container FDA UDI
Device Name: Sharps container: A device designed as a container to allow the safe deposit and collection of biologically or chemically contaminated used sharps; this includes needles, lancets, scalpel blades, cannulae, or other devices that present a hazard to a healthcare worker or patient if they were to inadvertently have bodily contact with the device and cause themselves an injury. This container is typically designed to be puncture resistant, leak-proof, and closable (usually having a lid that cannot be reopened once closed) and is identified with the universal biohazard symbol on its labelling. It is disposed of when filled to the recommended level. FDA UDI
Model / Reference: 3 Gallon FDA UDI
Description: Sharps container: A device designed as a container to allow the safe deposit and collection of biologically or chemically contaminated used sharps; this includes needles, lancets, scalpel blades, cannulae, or other devices that present a hazard to a healthcare worker or patient if they were to inadvertently have bodily contact with the device and cause themselves an injury. This container is typically designed to be puncture resistant, leak-proof, and closable (usually having a lid that cannot be reopened once closed) and is identified with the universal biohazard symbol on its labelling. It is disposed of when filled to the recommended level. FDA UDI

Identifiers

Catalog Number: 3 Gallon FDA UDI
Primary DI / UDI-DI: 00853022008123 FDA UDI
510(k) Number: K151249 FDA UDI
FDA Product Code: MMK 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

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Total Volume — 3.0 Gallon FDA UDI

Category: Sharps container

Sharps by Pureway Compliance, 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

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: Pureway Compliance, Inc.

Sources (1)

FDA UDI 807eed3a-e922-4b1a-afd3-1e36dd89d4bd 36 fields · synced May 30, 2026