Organization name

BioHorizons Implant Systems Inc.

SRN

US-MF-000014002

Manufacturer status

Active

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

Primary placement in Germany; available across 22 countries total.

Trade name

BioHorizons

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.

00847236017675

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.

08472360IIAINST002Q5

Reference / catalog number

GD-4528

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

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

Status

On the market

Quantity

1

Additional product description

Guided Drill, Blue, 4.5 x 28mm

Additional information URL

https://ifu.biohorizons.com/

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.

• Q010399SURGICAL DENTAL DEVICES - OTHER

• Class IIa medical devices in EUDAMED