Organization name

Aspen Surgical Products, Inc.

SRN

US-MF-000008255

Manufacturer status

Active

No certificate specifically references this device's Basic UDI-DI.

1 warning recorded — scroll inside the panel to see all entries.

• CW999

  Warnings: • Aspen reusable instruments are provided NON-STERILE and must be cleaned and sanitized according to these instructions prior to use. • If present, safety caps and other protective packaging material must be removed from the instruments prior to the first cleaning and sterilization. • Ethylene oxide [EO], gas plasma and dry heat sterilization methods are not recommended for sterilization of Aspen reusable instruments. Steam (moist heat) is the recommended method. • Personal Protective Equipment [PPE] should be worn when handling or working with contaminated or potentially contaminated instruments

Primary placement in Germany; available across 32 countries total.

Trade name

Symmetry ®

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

00887482144558

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

08401132CuretteHJ

Reference / catalog number

29-5401

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

https://www.aspensurgical.com/Resources/Documents/IFUs

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• L0399GENERAL SURGERY INSTRUMENTS, REUSABLE - OTHER

• Class I medical devices in EUDAMED