Organization name

Conmed Corporation

SRN

US-MF-000012663

Manufacturer status

Active

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

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

Primary placement in Belgium; available across 31 countries total.

Trade name

BioScrew HyperFlex

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.

10845854041710

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-10845854041710

Reference / catalog number

C8026D

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

BIOSCREW HYPERFLEX GUIDEWIRE, NITINOL 14 IN, STERILE, 1.1 x 356 mm (.045 x 14 in)

Additional information URL

https://eifu.conmed.com/eifu/

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.

• K030202ARTHROSCOPY GUIDE WIRES, SINGLE-USE

• Class IIa medical devices in EUDAMED

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