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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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Surgical Gown, AAMI LV3, Reinforced XL
Calico Medical Group LLC
SG011
In Commercial Distribution

  • 10850044458896 ()
  • 00850044458899 ()
SG011

  • Surgical gown, single-use
Surgical Gown, AAMI LV3, Reinforced L
Calico Medical Group LLC
SG010
In Commercial Distribution

  • 10850044458889 ()
  • 00850044458882 ()
SG010

  • Surgical gown, single-use
Surgical Gown, AAMI LV2, Non-Reinforced, XL
Calico Medical Group LLC
SG009
In Commercial Distribution

  • 10850044458872 ()
  • 00850044458875 ()
SG009

  • Surgical gown, single-use
Surgical Gown, AAMI LV2, Non-Reinforced, L
Calico Medical Group LLC
SG008
In Commercial Distribution

  • 10850044458865 ()
  • 00850044458868 ()
SG008

  • 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
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
SC301L
In Commercial Distribution

  • 00850037694136 ()
  • 00850037694099 ()


  • 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
MACI Arthroscopic Cutting Block
VERICEL CORPORATION
89060
In Commercial Distribution

  • 00850037506279 ()
N/A

  • Surgical cutting/shaping board, single-use
The Cartilage Biopsy Transport Kit, developed by Vericel Corporation, provides a way for surgeons to preserve a live cartilage biopsy and return it to the Vericel Cambridge Manufacturing Facility for the production of MACI - (Container, specimen mailer and storage, temperature controlled, sterile)
VERICEL CORPORATION
0
In Commercial Distribution

  • 00850037506194 ()


  • Specimen container mailer, insulated
  • Cell culture medium IVD
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