Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

Apex Tibial Nail Ø 12 x 390mm — Class IIb MDD by OrthoXel DAC

MD Atlas
OrthoXel DAC

EUDAMED last updated this device on May 16, 2024

Apex Tibial Nail Ø 12 x 390mm

B-05391529584948

On the marketClass IIb

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: OrthoXel DAC
UDI-DI code: 05391529584948
Reference / catalog number: T02-120390

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

Organization name: OrthoXel DAC
SRN: IE-MF-000000574
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Ireland; available across 1 country total.

Country	On market since	Until
IrelandPrimary placement		Still on market

Device identification

Trade name: Apex Tibial Nail Ø 12 x 390mm
UDI-DI code: 05391529584948
Basic UDI-DI: B-05391529584948
Reference / catalog number: T02-120390
Issuing entity: GS1

Classification

Risk category: Class IIb
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

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.

EMDN nomenclature code(s)

P09120201INTRAMEDULLARY NAILS

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

"Orange Ø4.9mm Twist Drill X Length 370mm (Use Ø6.0mm Locking Screw)"B-05391529582661On the market 3.5mm Hex Short Driver Shaft539152958517474On the market 3.5mm Hex Short Driver ShaftB-05391529585174On the market AO Mount Drill Extension (Length 136.5mm)B-05391529584207On the market Apex Femoral Nail GT Right Ø 11.0 x 380mmB-05391529587055On the market

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.