FENESTRADO FIELD

SURGICAL FIELD FENESTRATED WITH WINNER STERILE STICKER

ANVISA REGISTRATION: 80201960269

PRODUCT CODE: 1133

 

Category:

Description

COMPOSITION:

THE SURGICAL FIELD FENESTRATED WITH STERILE WINNER ADHESIVE IS MANUFACTURED IN NON WOVEN (SMS, SMMS) 100% POLYPROPYLENE. SMS IS COMPOSED OF THREE UNITED LAYERS THROUGH THERMAL, ATOXIC AND LATEX-FREE CALENDERING. THE ADHESIVE TAPE IS A HOTMELT ADHESIVE BASED ON EVA (ETHYLENE VINYL ACETATE).

 

SHELF LIFE:

5 YEARS FROM THE MANUFACTURING DATE. 

 

INDICATION AND PURPOSE OF USE: 

THE SURGICAL FIELD FENESTRATED WITH STERILE WINNER ADHESIVE HAS BEEN DEVELOPED TO PROVIDE GREATER ADHESION OF THE FIELD TO THE SURFACE AND / OR THE BODY OF THE PATIENT, AND MINIMIZING IMPORTANTLY THE RISKS OF CONTAMINATION OF THE CIRCUIT, THEREFORE, IN MISSION THE FIELD IS A PHYSICAL BARRIER FOR THE PROPAGATION OF MICRO-ORGANISMS, AVOIDING CONTAMINATION OF THE ENVIRONMENT AND PROTECTING THE USER.

 

PRECAUTIONS, RESTRICTIONS, WARNINGS, SPECIAL PRECAUTIONS AND CLARIFICATIONS ABOUT THE USE OF THE PRODUCT:

  • PRODUCT FOR EXTERNAL USE; 
  • SINGLE USE PRODUCT; 
  • STERILE PRODUCT;
  • APIROGENIC PRODUCT, LATEX AND Nontoxic FREE, NOT GENERALLY OFFERING USER RISK;
  • PRODUCT READY TO USE;
  • DO NOT USE THE PRODUCT IF YOU ARE ALLERGIC TO ANY COMPONENT;
  • DO NOT USE THE PRODUCT FOR ANY OTHER PURPOSE OTHER THAN THE ONE FOR WHICH IT IS INTENDED;
  • OBSERVE THE INSTRUCTIONS FOR USE CAREFULLY;
  • STORE IN A COOL AND DRY PLACE, UNDER SUN AND HUMIDITY;
  • DO NOT USE THE PRODUCT IF ITS ORIGINAL PACKAGING SHOW SIGNS OF VIOLATION OR EXPIRED DATE OF EXPIRATION;
  • OPEN THE PACKAGE ONLY AT THE TIME OF USE AND ASEPTICALLY;
  • THE STERELITY OF THE MATERIAL IS ONLY GUARANTEED WHILE THE PACKAGE REMAINS SEALED AND INTEGRATED;
  • DISPOSE OF AFTER USE IN AN APPROPRIATE PLACE.

 

ADVERSE EFFECTS:

NO ADVERSE EFFECTS TO THE USE OF THIS PRODUCT ARE REPORTED. 

 

PRODUCT PRESENTATION WAYS:

THE PRODUCT PRESENTS IN PRIMARY PACKAGING WITH 1 UNIT PACKED IN SURGICAL GRADE PAPER AND IN A SECONDARY PACKING OF CARDBOARD BOXES BEING PACKED FROM 100 TO 200 UNITS, DEPENDING ON THE SIZE OF THE SURGICAL FIELD, BOTH DEADLY IDENTIFIED. FENESTRA MAY PRESENT OVAL, SQUARE, ROUND OR RECTANGULAR, AND IN DIFFERENT DIMENSIONS TO DEPEND ON THE NEED.

 

INSTRUCTIONS FOR USE:

  1. OBSERVE THE INTEGRITY OF THE PACKAGING AND THE INFORMATION CONTAINED IN THE SAME;
  2. OPEN THE PACKAGING FROM THE LOCATION INDICATED, BEING CAREFUL NOT TO CONTAMINATE PARTS OF THE PRODUCT;
  3. DELAY : 1160 OPEN THE PACKAGE ASSEPTICALLY AND DISPOSE ON THE SURGICAL TABLE, ACCORDING TO THE NEED;
  4. ATTACH THE ADHESIVE ON THE SURFACE AND / OR ON THE PATIENT'S BODY IN THE MOST SUITABLE FORM FOR THE POSITIONING OF THE FIELD;
  5. THE PRODUCT IS READY TO BE USED AT THE APPLICATION PLACE;
  6. AFTER USE DISPOSE OF AT AN APPROPRIATE PLACE;
  7. DO NOT REUSE.

 

MANUFACTURER:

WINNER INDÚSTRIA DE DESCARTÁVEIS LTDA

CNPJ: 05.421.585/0001-37

RUA MACAÚBA, LOTE 01 – ÁGUAS CLARAS

BRASÍLIA – DF CEP: 71928-180

TEL: (61) 3435-6750 / 3435-6754