Base 2 Outrigger Components

Organization name

North Coast Medical Inc.

SRN

US-MF-000009087

Manufacturer status

Active

6 warnings recorded — scroll inside the panel to see all entries.

• Avoid direct contact of components with open wounds or damaged skin.

  OTHER

• Do not attempt to punch or drill holes in the thermoplastic while it is on the patient's hand.

  OTHER

• Choking Hazard - Keep out of reach of children.

  OTHER

• Discontinue use or adjust fit if patient shows signs of irritation, impaired circulation, increased pain or discomfort, or allergic reactions such as redness, itching, tingling, rash, or color changes in the affected area.

  OTHER

• Use of the Outrigger Kit for other than its intended purposes may cause injury.

  OTHER

• Caution

  Patient should have appropriate skin hygiene practices to prevent complications associated with prolonged splint use. Store Outrigger Kit and components in a clean and dry area.

Primary placement in Ireland; available across 10 countries total.

Trade name

Base 2 Outrigger Components

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.

00768627015165

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.

0768627CSTACC-1652-SG

Reference / catalog number

NC12830-0

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

Base 2 Straight Aluminum, 7 in (3)

Additional information URL

https://www.ncmedical.com/products/base-2-outrigger-components_1652.html?objectID=1652&queryID=d0137a895e6d23f583b3f076c158d429

Clinical sizes

• 7"

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

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

• M030504IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES

• Class I medical devices in EUDAMED

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