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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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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
SC300XXL
In Commercial Distribution

  • 00850037694075 ()
  • 00850037694037 ()


  • 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
SC300L
In Commercial Distribution

  • 00850037694051 ()
  • 00850037694013 ()


  • 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
The Insides Neo x1 Pouch
THE INSIDES COMPANY LIMITED
PS028
In Commercial Distribution

  • 09421905447218 ()
  • 09421905447195 ()
  • 09421905447201 ()


  • ENFit/ENFit linear connector
Patient examination glove made from nitrile compound, blue color, powder free and non-sterile (Per 21 CFR 880.6250, Class I). The device meets the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application. See product packaging for size identification. Carton of 100 pieces/inner box.
The Stronghold Group LLC
FRSNS-LYDUSNTRL
In Commercial Distribution

  • 00711583360954 ()
  • 00711583361104 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
No Description
BABYDUST METHOD LLC, THE
BDW2-S
In Commercial Distribution

  • 00869220000326 ()


  • Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical
Extra-Large Vinyl 4MIL Clear Powder-Free Exam Grade Gloves
The Cannon Group, Inc.
UMS03005
In Commercial Distribution

  • 10705689018120 ()
  • 00705689018123 ()


  • Vinyl examination/treatment glove, non-powdered
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