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

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Organization name
UDI-DI code
Reference / catalog number

OTNI Offsetplate 10mm — Class I MDR by OTN Innovations B.V.

MD Atlas
OTN Innovations B.V.

EUDAMED last updated this device on Mar 19, 2024

OTNI Offsetplate 10mm

8719992794OTNI1769

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: OTN Innovations B.V.
UDI-DI code: 08719992794157
Reference / catalog number: OTNI 1710

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View device family (Basic UDI)

Manufacturer information

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

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 Offsetplate 10mm
UDI-DI code: 08719992794157
Basic UDI-DI: 8719992794OTNI1769
Reference / catalog number: OTNI 1710
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 Offsetplate is a component used to provide correct alignment of the exo-prothesis with respect to the angle of bone anchored implant. The OTNI 1710 provides 10mm offset.
Additional information URL: https://otninnovations.com/product/luci/
Clinical sizes: 0–125 MU29
Lower extremity protheses

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08719992794157

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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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Related devices

OTNI Luci Connector8719992794OTNI1769On the market OTNI Luci Female Part8719992794OTNI1769On the market OTNI Luci Female Set8719992794OTNI1769On the market OTNI Luci Grit plate8719992794OTNI1769On the market OTNI Luci Lip Set8719992794OTNI1769On 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.