Omega Black Thermoplastic

Organization name

North Coast Medical Inc.

SRN

US-MF-000009087

Manufacturer status

Active

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

• Thermoplastic may be hot when removed from splint pan. Handle with caution to avoid skin burns.

  OTHER

Primary placement in Sweden; available across 10 countries total.

Trade name

Omega Black Thermoplastic

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.

00768627008815

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-2690-T9

Reference / catalog number

NC13300-1B

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

Omega Black 3/32 18 x 24 in (1)

Additional information URL

https://www.ncmedical.com/products/omega-black-thermoplastic_2690.html?objectID=2690&queryID=9677f5a16c909a251779f8c7a2c90140

Clinical sizes

• Dimension — 18–24 MU28

• 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.