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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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Titanium abutment designed as an endosseous dental implant retentive component used to retain a complete or partial denture. The device is screwed into an endosseous implant in the mandible or maxilla.
RHEIN 83 SRL
S/B/M BONE LEVEL RC ø 4,1/4,8 h 2 TiN
Not in Commercial Distribution

  • D821003BLR2R0 ()
003BLR2R

  • Surgical instrument handle, non-torque-limiting
Titanium abutment designed as an endosseous dental implant retentive component used to retain a complete or partial denture. The device is screwed into an endosseous implant in the mandible or maxilla.
RHEIN 83 SRL
S/B/M BONE LEVEL RC ø 4,1/4,8 h 1 TiN
Not in Commercial Distribution

  • D821003BLR1R0 ()
003BLR1R

  • Dental implant suprastructure, permanent, preformed
Kit Includes: T009C-D C-Series FlipTop™ Cassette - Double Rack 18 R043 Amazing Gracey™ 13-14 Extended Reach R044 Amazing Gracey™ 15-16 Extended Reach R061 Barnhart 5-6 R089 Mini Me™ R120 Montana 4-5™ R130 Jack B. Nimble® R138 Montana Jack® R144 Queen of Hearts™ R169 11-12 ODU Extended Reach Explorer R216 ACE™-12 Short Probe R245 Cone Socket Mirror Handle T042 Meriam Tweezers T050 #5 Mirror (15/16")
PDT, INC.
R916 PDT SRP Kit
In Commercial Distribution

  • 00813677024855 ()
R916

  • Manual dental scaler, reusable
  • Periodontal curette
  • Dental surgical probe, reusable
  • Instrument tray, reusable
  • Manual non-rotary dental instrument handle
  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
  • Dental mirror, reusable
The 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.
MEDTECS (TAIWAN) CORP.
JCSG74700XXL
In Commercial Distribution

  • 14710415369175 ()
  • 04710415369178 ()


  • Surgical gown, single-use
The 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.
MEDTECS (TAIWAN) CORP.
JCSG74700XL
In Commercial Distribution

  • 14710415369168 ()
  • 04710415369161 ()


  • Surgical gown, single-use
The 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.
MEDTECS (TAIWAN) CORP.
JCSG74700L
In Commercial Distribution

  • 14710415369151 ()
  • 04710415369154 ()


  • Surgical gown, single-use
The 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.
MEDTECS (TAIWAN) CORP.
JCSG74700M
In Commercial Distribution

  • 14710415369144 ()
  • 04710415369147 ()


  • 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
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
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