OSC 400-JP

Organization name

Oscimed SA

SRN

CH-MF-000009605

Manufacturer status

Active

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

• CW011

  EUDAMED did not publish a description for this code.
• CW029

  EUDAMED did not publish a description for this code.
• CW010

  EUDAMED did not publish a description for this code.
• CW016

  EUDAMED did not publish a description for this code.
• CW259

  Class II device with double electrical insulation, without protective grounding.
• CW258

  EUDAMED did not publish a description for this code.
• CW999

  The device is designed to meet the requirements of IEC 60601-1-2: 2015 regarding electromagnetic compatibility; however, certain equipment may unintentionally emit strong RF signals that may interfere with the device. It should be kept away from all other electrical devices. (In accordance with chapter 7.9.2.2 of IEC 60601-1-2).

Primary placement in Italy; available across 32 countries total.

Trade name

not provided

UDI-DI code

07640104924043

Basic UDI-DI

764010492PLASTERSAWEV

Reference / catalog number

OSC 400-JP

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

Medical device intended for the removal of plaster or synthetic resin immobilisation casts. All other use is strictly prohibited. In particular, this device is not designed for use where the blade comes into voluntary contact with the patient or for surgical procedures.

Additional information URL

https://www.oscimedsa.com/

Clinical sizes

No clinical sizes registered for this device.

• Z12139005PLASTER CAST SAWS

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification