PV00029

Organization name

i+Med S.Coop.

SRN

ES-MF-000008633

Manufacturer status

Active

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

• CW010

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

  The product is for single use. No reuse; risk of infection.
• CW001

  Do not re-sterilize, re-sterilization can affect the physicochemical properties of the product and compromise its effectivenessand safety.
• CW007

  The product should not be used if the package is damaged or broken.
• CW032

  The product should not be used after the expiration date.
• CW135

  BtHCROSS should not be administred to children. Keep out of children’s reach.
• CW276

  Do not administer BtHCROSS in immediate association with laser or pulsed light treatments.
• CW161

  BtHCROSS should not be administered to pregnant or breastfeeding women.
• CW999

  Do not administer BtHCROSS to patients with known hypersensitivity (allergy) to hyaluronic acid and / or other components of the product. Do not administer BtHCROSS to patients with acute or chronic dermatological disorders or an inflammatory and / or infectious type skin problem. Do not administer BtHCROSS to patients with coagulation defects and / or who are treated with anticoagulant medication. BtHCROSS should not be injected into blood vessels or eyelids; intravascular injection may produce embolization, occlusion of the vessels, ischemia, blindness or infarction. BtHCROSS should be administered exclusively by intradermal injection following a strict aseptic procedure. BtHCROSS should be administered with sterile Luer-lock needles (as supplied with the product). It is recommended that the patient do not wear makeup for 12 hours after the injection and avoid prolonged exposure to the sun, to ultraviolet rays, at temperatures below 0°C, as well as the sauna or Turkish bath during two weeks following the injection.

Primary placement in Spain; available across 2 countries total.

Trade name

not provided

UDI-DI code

08437015992075

Basic UDI-DI

B-08437015992075

Reference / catalog number

PV00029

Issuing entity

GS1

Risk category

Class III

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 1 MU48

• P900402RESORBABLE FILLING AND RECONSTRUCTION DEVICES

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