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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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This gown is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate materials. Not intended for use in the operating room. This gown is classified as Level 2 per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities. Pack of 10.
The Stronghold Group LLC
SC200S
In Commercial Distribution

  • 10850037694645 ()
  • 00850037694648 ()


  • Isolation gown, single-use
The Stronghold SMS Reinforced Gown is a device that is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. It is made from SMS material, and is full length, constructed with raglan sleeves, hook and loop neck closures, and tie waist closures. The reinforcement has the following structural features: (a) The chest area is reinforced with additional layer of SMS material. (b) The sleeve area is reinforced with additional layer of SMS material. The gowns are sterilized with EtO sterilization IAW ISO 11135.
The Stronghold Group LLC
SC301XXL
In Commercial Distribution

  • 00850037694150 ()
  • 00850037694112 ()


  • Surgical gown, single-use
The Stronghold SMS Reinforced Gown is a device that is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. It is made from SMS material, and is full length, constructed with raglan sleeves, hook and loop neck closures, and tie waist closures. The reinforcement has the following structural features: (a) The chest area is reinforced with additional layer of SMS material. (b) The sleeve area is reinforced with additional layer of SMS material. The gowns are sterilized with EtO sterilization IAW ISO 11135.
The Stronghold Group LLC
SC301XL
In Commercial Distribution

  • 00850037694143 ()
  • 00850037694105 ()


  • Surgical gown, single-use
The Stronghold SMS Reinforced Gown is a device that is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. It is made from SMS material, and is full length, constructed with raglan sleeves, hook and loop neck closures, and tie waist closures. The reinforcement has the following structural features: (a) The chest area is reinforced with additional layer of SMS material. (b) The sleeve area is reinforced with additional layer of SMS material. The gowns are sterilized with EtO sterilization IAW ISO 11135.
The Stronghold Group LLC
SC301M
In Commercial Distribution

  • 00850037694129 ()
  • 00850037694082 ()


  • Surgical gown, single-use
The Stronghold SMS Reinforced Gown is a device that is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. It is made from SMS material, and is full length, constructed with raglan sleeves, hook and loop neck closures, and tie waist closures. The reinforcement has the following structural features: (a) The chest area is reinforced with additional layer of SMS material. (b) The sleeve area is reinforced with additional layer of SMS material. Non-sterile surgical gowns are to be sold to OEMs for EtO sterilization according to ISO 11135. Sterile Surgical Gowns are to be sold directly to users after EtO sterilization validation to ISO 11135.
The Stronghold Group LLC
SC300XL
In Commercial Distribution

  • 00850037694068 ()
  • 00850037694020 ()


  • Surgical gown, single-use
The Stronghold SMS Reinforced Gown is a device that is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. It is made from SMS material, and is full length, constructed with raglan sleeves, hook and loop neck closures, and tie waist closures. The reinforcement has the following structural features: (a) The chest area is reinforced with additional layer of SMS material. (b) The sleeve area is reinforced with additional layer of SMS material. Non-sterile surgical gowns are to be sold to OEMs for EtO sterilization according to ISO 11135. Sterile Surgical Gowns are to be sold directly to users after EtO sterilization validation to ISO 11135.
The Stronghold Group LLC
SC300M
In Commercial Distribution

  • 00850037694006 ()


  • Surgical gown, single-use
2x2mm hook; 37mm x 0.75mm electrode; 1.9m twisted wire with DIN42802 connector
THE MAGSTIM COMPANY LIMITED
4009-00
Not in Commercial Distribution

  • 05060229531346 ()


  • Nerve-locating system probe, single-use
2.3mm Ball; 130mm x 1.9mm electrode; 1.9m wire with DIN42802 connector
THE MAGSTIM COMPANY LIMITED
4008-00
Not in Commercial Distribution

  • 15060229531336 ()
  • 05060229531339 ()


  • Nerve-locating system probe, single-use
3mm Ball; 200mm x 1mm electrode; 1.9m wire with DIN42802 connector
THE MAGSTIM COMPANY LIMITED
4006-00
Not in Commercial Distribution

  • 05060229531315 ()


  • Nerve-locating system probe, single-use
3 x 2mm hook; 37mm x 0.75mm electrode; 1.9m twisted wire with DIN42802 connector
THE MAGSTIM COMPANY LIMITED
4003-00
Not in Commercial Distribution

  • 05060229531285 ()


  • Nerve-locating system probe, single-use
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