Bayflex

Dénomination commerciale

Bayflex

08904085093563

B-08904085093563

Numéro de référence/catalogue

BASP 1003

GS1

Classe III

Législation applicable

MDD [Directive 93/42/CEE relative aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

Sterile Haemostatic Absorbable Gelatin Sponge – IP/USP is a hemostatic absorbable medical device manufactured from highly purified neutral gelatin material of porcine origin. It is a white, light white or almost white water-insoluble, highly porous, pliable product intended for application to bleeding surfaces as a hemostat during surgical procedures when use of conventional bleeding control procedures are ineffective, difficult to apply or impractical. The uniform porosity of BAYFLEX ® enables the fluid volume to hold on the bleeding site and creates a physical pressure resulting in an accelerated hemostasis. It adheres well to the bleeding site and can absorb blood or body fluids not less than 35 times of its own weight and assists in achieving hemostasis in 3 to 6 minutes. Sterile Haemostatic Absorbable Gelatin Sponge – IP/USP is biocompatible as per applicable EN ISO 10993 standards. Sterile Haemostatic Absorbable Gelatin Sponge – IP/USP is manufactured in different physical formats and/or shapes to suit the needs of surgeons for application for an effective hemostasis in different types of surgeries.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

• 125x80x10 mm

Nomenclature européenne des dispositifs médicaux — la classification produit UE attribuée à ce dispositif.

• M040503GELATINE SPONGE HAEMOSTATIC DRESSINGS

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• PRECAUTIONS & WARNINGS: • Product for use by Registered Medical Practitioner or a Hospital or a Laboratory. • This product is not designed, sold or intended for use except as indicated. Keep out of reach of children. • BAYFLEX ® is to be used as an adjunct and is not intended to be substitute for meticulous surgical technique and the proper application of ligatures or other conventional procedures for hemostasis. • To prevent contamination, employ aseptic procedure in opening envelope and withdrawing BAYFLEX ®. If the package is torn or punctured, the contained BAYFLEX ® should not be used. • The use of BAYFLEX ® is not recommended in the presence of infection. BAYFLEX ® should be used with caution in contaminated areas of the body. Once hemostasis is achieved any excess BAYFLEX ® should be carefully removed to prevent the possibility of dislodgment of the device or compression of other nearby anatomic structures.

  AUTRE

• • BAYFLEX ® should be removed from the site of application when used in, around, or in proximity to foramina in bone, areas of bony confine, the spinal cord and/or the optic nerve and chiasm. This is because BAYFLEX ® may swell to its original size on absorbing fluids, and produce nerve damage by pressure within confined bony spaces. This may interfere with normal function and/or possibly result in compression necrosis of surrounding tissues. • BAYFLEX ® should not be used for the primary treatment of coagulation disorders. • BAYFLEX ® should not be used for controlling post-partum intrauterine bleeding or menorrhagia. • Upon application, if signs of irritation (redness), maceration (whitening of surrounding skin) or itching develop, remove and discontinue use of BAYFLEX ® and consult a healthcare professional. • In case BAYFLEX ® is left at the bleeding site and signs of infection such as fever, increased pain, bleeding, swelling, unusual odour, cloudy or foul drainage or abscess develop at the site, remove the infected material and consult a healthcare professional immediately. • Although the safety and effectiveness of the combined use of BAYFLEX ® with other agents such as topical thrombin, antibiotic solution or antibiotic powder has not been evaluated in controlled clinical trials, if in the physician's judgment, concurrent use of topical thrombin or other agents is medically advisable, the product literature for that agent should be consulted for complete prescribing information.