OSTEOPEARL

Organization name

BIOPSYBELL SRL

SRN

IT-MF-000011601

Manufacturer status

Active

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

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

• Caution
• Consult instructions for use
• Do not re-use
• Do not use if package is damaged
• Do not resterilize
• Do not use past indicated date

Primary placement in Italy; available across 11 countries total.

Trade name

OSTEOPEARL

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.

08033860044893

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-08033860044893

Reference / catalog number

100.432

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

—

Additional information URL

No additional information URL provided by the manufacturer.

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.

• K010301SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON

• Class IIa medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.