DSG Pin #5

Organization name

SpineGuard.S.A

SRN

FR-MF-000004720

Manufacturer status

Active

Primary placement in France; available across 13 countries total.

Trade name

DSG Pin #5

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.

03662674000198

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.

B-03662674000198

Reference / catalog number

D1PU0005

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 IIa

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

The DSG Pin transmits the electrical signal back and forth between the electronic handle and the tip of the pin during drilling of the pedicle or the vertebral body of the vertebra.

Additional information URL

https://www.spineguard.com/products-and-applications/spine-products/user-manuals/pgt-brochure/

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.

• Z12139099VARIOUS ORTHOPAEDIC AND TRAUMATOLOGY INSTRUMENTS - OTHER

• Class IIa medical devices in EUDAMED

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

Certificate health across this manufacturer's portfolio.