NeoNavia FlexiPulse probe

Organization name

Neonavia AB

SRN

SE-MF-000045971

Manufacturer status

Active

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

• CW999

  NeoNavia® is for diagnostic use only and is not indicated for therapeutic use. NeoNavia® is contraindicated for those patients where increased risk of complications may be associated with percutaneous removal of tissue samples upon the physician’s judgment. Patients receiving anticoagulant therapy or who may have bleeding disorders may be at increased risk.
• CW010

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

  Potential complications are those associated with any percutaneous removal/biopsy technique for tissue collection. Potential complications are limited to the region surrounding the biopsy site and include hematoma, hemorrhage, infection, pain, and tissue adherence to the biopsy needle while removing it from the breast or axilla.
• CW027

  Use ultrasound guidance when you operate NeoNavia®, to visualize the movements of the device. Do not use MRI or stereotactic guidance. The NeoNavia® is MR unsafe.
• CW001

  Do not re-sterilize NeoNavia® biopsy probes. They are intended for single patient use only. The use of re-sterilized components, intended for single patient use only, can result in infection or injury of the patient.
• CW009

  Do not use NeoNavia® biopsy probes more than once. They are intended for single patient use only. If components that are intended for single patient use only are used again, it can result in infection or injury of the patient.
• CW007

  Do not use NeoNavia® biopsy probes if the sterile package is broken or damaged or if the Use by date has passed.
• CW032

  Do not use NeoNavia® biopsy probes if the sterile package is broken or damaged or if the Use by date has passed.
• CW008

  Use applicable personal protective equipment following local guidelines (for example gloves), during operation and maintenance of NeoNavia®, to prevent exposure to biohazards.
• CW999

  Follow instructions for use!

Primary placement in Germany; available across 1 country total.

Trade name

NeoNavia FlexiPulse probe

UDI-DI code

17350081940079

Basic UDI-DI

735008194NEONAVIAPROBED2

Reference / catalog number

REF# 2104

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

https://neonavia.se/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.

• A01020199NEEDLES AND KITS FOR HISTOLOGICAL AND CYTOLOGICAL BIOPSY OF SOFT TISSUES - OTHER