Organization name

AprioMed AB

SRN

SE-MF-000001013

Manufacturer status

Active

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

• CW999

  Precaution 3: Before use, inspect the device for damaged needle point, bent shaft or other imperfections that would prevent proper function. If the needle components are damaged or bent or do not move together easily, do not use.
• CW999

  Precaution 4: Administration of local anesthesia must be conducted by, or under supervision of physician with experience of regional anesthesia in accordance with the drug and syringe manufacturer instructions
• CW999

  Corbo Coaxial® Needle is intended for use in image-guided procedures only. Verify the device location using imaging techniques after every device adjustment. Do not use Corbo Coaxial® Needle in Magnetic Resonance Imaging (MRI) equipment. The device is magnetic and exposure to MRI may cause unintended device movement
• CW999

  Precaution 2: Before use together with other equipment, check the compatibility in length and gauge together with Corbo Coaxial® Needle.
• CW011

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

  Contraindication: Not intended for use in the bone.
• CW999

  Good medical judgement should be exercised in considering biopsy on patients who are receiving anticoagulant therapy or who have bleeding disorders. Use in these patient populations may result in severe bleeding.
• CW999

  Precaution 1: Corbo Coaxial® Needle must be used by a physician who is completely familiar with the indications, contraindications, limitations, typical findings and possible side effects of core needle biopsy, in particular, those relating to the specific organ being biopsied
• CW999

  Precaution 5: After use, the components may be a potential biohazard. Handle and dispose of in accordance with accepted medical practice and applicable local, state and federal laws and regulations.
• CW027

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

  EUDAMED did not publish a description for this code.
• CW007

  EUDAMED did not publish a description for this code.
• CW009

  EUDAMED did not publish a description for this code.
• CW001

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

  Do not use excessive force against resistance. If the needle is damaged or bent, do not use. Retract the bent part simultaneously with the rest of the device to prevent needle breakage and materials remaining in the body
• CW999

  One potential complication of coaxial image-guided biopsy is inadvertent perforation of adjacent structures. Inadvertent perforation may result in site specific complications which may consist of bleeding, including bleeding from the large artery, hematoma, hemorrhage, infection, pain, cardiac tamponade, pneumothorax, hemoptysis and hemothorax.

Primary placement in Sweden; available across 32 countries total.

Trade name

Corbo Coaxial Needle 19G, 17 cm

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

07350031350616

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

73500313519KY

Reference / catalog number

CCN19G-17

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

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://apriomed.com/wp-content/uploads/29594.pdf

Clinical sizes

• 17 MU10
• 19

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

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

• A0102010101SHEARING BIOPSY NEEDLES

• Class IIa medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.