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Organization name
UDI-DI code
Reference / catalog number

OTNI Male Part Extender — Class I MDR by OTN Innovations B.V.

MD Atlas
OTN Innovations B.V.

EUDAMED last updated this device on Jun 4, 2024

OTNI Male Part Extender

8719992794OTNI1769

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: OTN Innovations B.V.
UDI-DI code: 08719992794508
Reference / catalog number: OTNI 80MPEX

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View device family (Basic UDI)

Manufacturer information

Organization name: OTN Innovations B.V.
SRN: NL-MF-000023058
Manufacturer status: Active

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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.

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Netherlands; available across 1 country total.

Placed on the market in Netherlands; per-country availability dates not published.

Device identification

Trade name: OTNI Male Part Extender
UDI-DI code: 08719992794508
Basic UDI-DI: 8719992794OTNI1769
Reference / catalog number: OTNI 80MPEX
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: The OTNI 80MPEX Male-part Extender is a titanium extension piece which needs to be placed in between the OTNI 1709 male part and the compatible bone anchoring device. The OTNI 80MPEX Male-part Extender is a custom device to make sure the OTNI 1709 male part has a secure connection to different kind of bone anchoring devices.
Additional information URL: https://otninnovations.com/en/accessoires/
Clinical sizes: 0–125 MU29
Lower limb amputee

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08719992794508

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

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

Y062499LOWER EXTREMITY PROSTHESES - OTHER

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

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