SG13-171

Organization name

AprioMed AB

SRN

SE-MF-000001013

Manufacturer status

Active

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

• CW999

  In case of bending of any part of the coaxial system, stop the procedure and retract the bent part simultaneously with the rest of the device. Removing bent parts only may cause breakage and result in materials remaining in the body.
• CW999

  Precaution 1: Before use together with other equipment, check the compatibility in length and gauge together with Gangi SoftGuard® using the reference guide included in the package.
• CW999

  Precaution 3: 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
• CW999

  Contraindication: Not intended for use in bone
• CW999

  Precaution 2: Before use, inspect the device for damaged 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: Gangi SoftGuard® 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

  Gangi-SoftGuard® is intended for use in image-guided procedures only. Verify the device location using imaging techniques after every device adjustment. Do not use Gangi-SoftGuard® in Magnetic Resonance Imaging (MRI) equipment. The device is magnetic and exposure to MRI may cause unintended device movement.
• 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
• CW027

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

  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

  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.

Primary placement in Sweden; available across 32 countries total.

Trade name

not provided

UDI-DI code

07350031350364

Basic UDI-DI

73500313512KJ

Reference / catalog number

SG13-171

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://apriomed.com/wp-content/uploads/29604.pdf

Clinical sizes

• 17.1 MU10
• 13

• 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