Sterile Resorbable Hemostatic Compresses (10) - Urgo Pangen (553175) - Delynov
The Pangen (10 compresses) hémostatique stérile résorbable - Urgo Pangen is a medical device manufactured by Laboratoires Urgo — Class III, CE marking CE0459.
- Compliance: Medical device Class III, CE marking CE0459.
- Manufacturer: Laboratoires Urgo.
- Reference: 553175.
- Reserved for healthcare professionals. Read instructions carefully before use.
fabricant : SYMATESE Z.I. Les Troques 69630 Chaponost .réservé aux professionnels de santé.Lire attentivement la notice avant utilisation.
What is Pangen (10 compresses) sterile absorbable haemostatic?
Pangen from the Urgo brand is a medical device designed to promote haemostasis during surgical interventions. Packaged in boxes of 10 compresses, this product comes in the form of a sterile and absorbable haemostatic material. Developed by Laboratoires Urgo, it is specifically intended for healthcare professionals for use in clinical or surgical environments. This Urgo Pangen device, bearing reference 553175, is a recognized solution in the management of capillary and parenchymatous bleeding. Its structure allows for easy handling by the practitioner while ensuring optimal safety thanks to its absorbable nature, thus avoiding a second intervention for its removal.
What are the clinical indications for Pangen Urgo?
The intended use of Pangen Urgo primarily concerns situations requiring rapid local haemostasis. Although detailed specific indications are not listed in the raw technical data, this device is classically used in oral, dental, and implant surgery to control bleeding when conventional methods are insufficient. As an absorbable compress, it is particularly suitable for surgical sites where maintaining a haemostatic agent in situ is necessary. This product is exclusively reserved for healthcare professionals trained in these technical procedures, in accordance with the directives of the manufacturer SYMATESE located in Chaponost.
What are the technical characteristics of product 553175?
Pangen Urgo (reference 553175) is defined by its haemostatic properties and its capacity for total resorption by the body. It is a Class III medical device, which demonstrates a high level of requirement regarding safety and clinical performance for implantable or long-term invasive devices. The product benefits from CE0459 marking, guaranteeing its compliance with current European standards. Each box contains 10 sterile units, ready to use for surgical interventions. Although the exact composition is not specified in the provided documentation, its design meets the essential biocompatibility needs for secure surgical application.
What are the contraindications for the use of this haemostatic device?
The use of Pangen Urgo must strictly follow clinical protocols. According to the warnings from the manufacturer SYMATESE, this device is strictly reserved for healthcare professionals. General contraindications for this type of absorbable material include known hypersensitivity to any of the components (although not specified here) or application in infected areas without appropriate concomitant treatment. It is imperative to read the instructions carefully before any use to identify specific restrictions related to the patient or the nature of the wound. Particular attention must be paid to maintaining sterility before application to the surgical site.
How does resorption take place and what are the precautions?
Pangen is an absorbable device, meaning it is designed to be degraded and eliminated naturally by the body after fulfilling its haemostatic function. This characteristic is essential in dental and oral surgery to avoid trauma related to the removal of non-absorbable dressings. The practitioner must ensure that the compress is optimally positioned on the bleeding area. As with any Class III device, post-operative follow-up is crucial to verify the absence of excessive inflammatory reaction. The instructions for use provided by Laboratoires Urgo specify the handling methods to guarantee the effectiveness of the in vivo resorption process.
Who is the manufacturer and what standards are met by Pangen?
Pangen is manufactured by SYMATESE (Z.I. Les Troques 69630 Chaponost) on behalf of the Urgo brand (Laboratoires Urgo). This medical device is certified Class III, meeting the strictest requirements of the Medical Device Regulation (MDR). It bears the CE0459 marking, attesting to its evaluation by a notified body. Reference 553175 guarantees the traceability of the product within the Urgo Pangen range. As a sterile and absorbable product intended exclusively for healthcare professionals, it respects the manufacturing and safety standards necessary for use in operating rooms or specialized dental practices.
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