Organization name

ZimVie US Corp LLC

SRN

US-MF-000048255

Manufacturer status

Active

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

Primary placement in Spain; available across 26 countries total.

Trade name

Single Patient Flat Bottom Countersink Drills

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.

00844868042563

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.

844868AFJ2

Reference / catalog number

FCS486SSP

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

—

Additional information URL

https://labeling.zimvie.com/

Clinical sizes

• 6 MU50
• 4.85 MU50

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

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

• Q010599DENTAL INSTRUMENTS, SINGLE-USE - OTHER

• Class IIa medical devices in EUDAMED