RADIAL / FEMURAL HEMODYNAMIC SURGICAL KIT

RADIAL / FEMURAL HEMODYNAMIC SURGICAL KIT WINNER

ANVISA REGISTRATION: 80201960173

PRODUCT CODE: 1449

Category:

Description

COMPOSITION:

THE WINNER RADIAL / FEMURAL HEMODYNAMIC SURGICAL KIT IS MANUFACTURED IN NON-WOVEN (SMS, SMMS) AND LAMINATED WITH VARIED GRAMMATURES, HYDRORPELLENT PROTECTION BARRIER AND EFFECTIVE BARRIER AGAINST BLOOD AND WASTE BODY, PURPOSE OF BODY AND WASTE BODY: TABLE, REINFORCED SURGICAL APRON, AND CASE, ALL IN POLYPROPYLENE; HAND TOWEL IN VISCOSE; GAZE WITH RADIOPAQUE MARKER MADE OF COTTON AND BARIUM SULFATE 60%; POLYETHYLENE SOLUTION CUP AND SPONGE; HIGH DENSITY POLYTENLENE TUBE COVER. THE COMPOSITION OF THE KIT, RELATING TO THE ITEMS THAT COMPOSES IT AND ITS DIMENSIONS, MAY VARY DEPENDING ON THE CUSTOMER'S NEED.

 

SHELF LIFE:

5 YEARS FROM THE EXPIRY DATE. 

 

INDICATION AND PURPOSE OF USE: 

THE WINNER RADIAL / FEMURAL HEMODYNAMIC SURGERY KIT WAS DEVELOPED TO MEET HOSPITAL NEEDS RELATING TO THE PERFORMANCE OF VASCULAR PROCEDURES OF UPPER AND / OR LOWER MEMBERS. MAY BE USED WHOLE OR IN PART, DEPENDING ON THE NEED AND / OR INDICATION OF THE PROCEDURE.

 

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

  • PRODUCT FOR EXTERNAL USE; 
  • SINGLE USE PRODUCT;
  • PROHIBITED REPROCESSING PRODUCT;
  • OBSERVE THE INSTRUCTIONS FOR USE CAREFULLY;
  • THE PRODUCT IS APIROGENIC AND Nontoxic AND DOES NOT GENERALLY RISK TO THE USER;
  • STERILE PRODUCT;
  • THE PRODUCT'S STERELITY IS ONLY GUARANTEED WHILE THE ORIGINAL PACKAGE REMAINS INTEGRATED AND SEALED;
  • STORE IN A FRESH AND DRY PLACE, UNDER HEAT AND HUMIDITY;
  • DO NOT USE THE PRODUCT IF ITS ORIGINAL PACKAGING SHOW SIGNS OF VIOLATION OR EXPIRED DATE OF EXPIRATION;
  • TRANSPORT THE PRODUCT ONLY IN ITS ORIGINAL PACKAGE;
  • OPEN THE PACKAGE ONLY AT THE TIME OF USE AND ASEPTICALLY;
  • SINGLE USE PRODUCT; 
  • 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 IS PRESENTED IN PRIMARY PACKAGE OF SURGICAL GRADE PAPER CONTAINING 01 KIT PER PACKAGE AND IN SECONDARY PACKAGES CONTAINING UP TO 10 KITS. THE COMPOSITION AND SIZING OF THE KIT ARE VARIED.

 

INSTRUCTIONS FOR USE:

  1. OBSERVE THE INTEGRITY OF THE PACKAGING AND THE INFORMATION CONTAINED ON THE LABELING;
  2. DO NOT USE THE PRODUCT IF THE PACKAGING PRESENTS SIGNS OF VIOLATION OR EXPIRED DATE / EXPIRATION DATE;
  3. OPEN THE PACKAGING FROM THE INDICATED LOCATION AND ASEPTICALLY AVOIDING CONTAMINATION OF PARTS OF THE PRODUCT;
  4. REMOVE ITEMS FROM THE KIT TO BE USED ACCORDING TO THE NEED OF THE PROCEDURE;
  5. DISPOSE OF ITEMS TO BE USED IN SUITABLE LOCATIONS FOR USE;
  6. PERFORM THE PROCEDURE;
  7. DISPOSE OF ITEMS USED, OR NOT, IN A PROPER LOCATION;
  8. 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