Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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The products are sterile with a Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. Each type has several models. Different models are distinguished by needle gauge and length. The Common Type Insulin Pen Needle consists of needle container, needle shield, needle tube, needle hub, UV glue and silicone oil. UV glue is used to glue needle tube and needle hub and the silicone oil is used to needle tube lubrication. The products are for OTC use, and they are external communication, blood indirect devices. The contact duration for both subjected devices is within 24h, and they belong to limited contact device according ISO 10993-1.
Promisemed Hangzhou Meditech Co., Ltd.
IPN-32-4
In Commercial Distribution

  • 16971227400069 ()
  • 06971227400062 ()
  • 86971227400068 ()


  • Autoinjector needle
The products are sterile with a Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. Each type has several models. Different models are distinguished by needle gauge and length. The Common Type Insulin Pen Needle consists of needle container, needle shield, needle tube, needle hub, UV glue and silicone oil. UV glue is used to glue needle tube and needle hub and the silicone oil is used to needle tube lubrication. The products are for OTC use, and they are external communication, blood indirect devices. The contact duration for both subjected devices is within 24h, and they belong to limited contact device according ISO 10993-1.
Promisemed Hangzhou Meditech Co., Ltd.
IPN-31-8
In Commercial Distribution

  • 16971227400052 ()
  • 06971227400055 ()
  • 86971227400051 ()


  • Autoinjector needle
The products are sterile with a Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. Each type has several models. Different models are distinguished by needle gauge and length. The Common Type Insulin Pen Needle consists of needle container, needle shield, needle tube, needle hub, UV glue and silicone oil. UV glue is used to glue needle tube and needle hub and the silicone oil is used to needle tube lubrication. The products are for OTC use, and they are external communication, blood indirect devices. The contact duration for both subjected devices is within 24h, and they belong to limited contact device according ISO 10993-1.
Promisemed Hangzhou Meditech Co., Ltd.
IPN-31-6
In Commercial Distribution

  • 16971227400045 ()
  • 06971227400048 ()
  • 86971227400044 ()


  • Autoinjector needle
The product is composed of basket assembly, sheath assembly and handle assembly. This product is intended for the endoscopic removal of stones and stone fragments in the biliary system.
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
EBF-1511S
In Commercial Distribution

  • 16971381252757 ()
  • 06971381252750 ()


  • Urinary stone retrieval basket, single-use
The product is composed of basket assembly, sheath assembly and handle assembly. This product is intended for the endoscopic removal of stones and stone fragments in the biliary system.
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
EBF-1511C
In Commercial Distribution

  • 16971381252740 ()
  • 06971381252743 ()


  • Urinary stone retrieval basket, single-use
The product is composed of basket assembly, sheath assembly and handle assembly. This product is intended for the endoscopic removal of stones and stone fragments in the biliary system.
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
EBF-1529C
In Commercial Distribution

  • 16971381252733 ()
  • 06971381252736 ()


  • Urinary stone retrieval basket, single-use
The product is composed of basket assembly, sheath assembly and handle assembly. This product is intended for the endoscopic removal of stones and stone fragments in the biliary system.
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
EBF-1529S
In Commercial Distribution

  • 06971381252729 ()
  • 16971381252726 ()


  • Urinary stone retrieval basket, single-use
The product is composed of a handle, a sliding handle, a flexible catheter and a head end, sterilized with ethylene oxide. This product is intended for biopsy of mucosal tissue and/or removal of foreign bodies under endoscope.
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
BFUN-1811
In Commercial Distribution

  • 16971381252191 ()
  • 06971381252194 ()
  • 26971381252198 ()


  • Flexible endoscopic biopsy forceps, single-use
The product is composed of a handle, a sliding handle, a flexible catheter and a head end, sterilized with ethylene oxide. This product is intended for biopsy of mucosal tissue and/or removal of foreign bodies under endoscope.
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
BFUW-1811
In Commercial Distribution

  • 16971381252184 ()
  • 06971381252187 ()
  • 26971381252181 ()


  • Flexible endoscopic biopsy forceps, single-use
The product is composed of basket assembly, sheath assembly and handle assembly. This product is intended to capture, manipulate and remove stones and other foreign bodies during urinary diagnosis and treatment under endoscope.
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
EBF-14
In Commercial Distribution

  • 16971381251675 ()
  • 06971381251678 ()


  • Biliary/urinary stone retrieval basket, single-use
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