OTS ™ Stylet and Pin

Organization name

Ortoma AB

SRN

SE-MF-000034945

Manufacturer status

Active

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

• CW010

  EUDAMED did not publish a description for this code.
• CW011

  EUDAMED did not publish a description for this code.
• CW265

  EUDAMED did not publish a description for this code.

Primary placement in Sweden; available across 5 countries total.

Trade name

OTS ™ Stylet and Pin

UDI-DI code

07350137520036

Basic UDI-DI

735013752OTSInstrument39

Reference / catalog number

30-117

Issuing entity

GS1

Risk category

Class I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

https://www.ortoma.com/ifu

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.

• Z12011401SURGICAL NAVIGATION SYSTEM