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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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GRI-BAG is a single-use, non-pyrogenic flexible empty container with incorporated 0.2 µ.m filter. It is supplied sterile in sealed peel-pack pouches and is available in volume capacities of 100 ml, 250 ml, 500 ml and 1000 ml. The GRI-BAG models have a twist-off valve output connector.
LABORATORIOS GRIFOLS SA
500
In Commercial Distribution

  • 28426314391478 ()
  • 08426314391474 ()
  • 08426314575690 ()


  • Compounding transfer set
  • Intravenous administration bag/bottle
GRI-BAG is a single-use, non-pyrogenic flexible empty container with incorporated 0.2 µ.m filter. It is supplied sterile in sealed peel-pack pouches and is available in volume capacities of 100 ml, 250 ml, 500 ml and 1000 ml. The GRI-BAG models have a twist-off valve output connector.
LABORATORIOS GRIFOLS SA
250
In Commercial Distribution

  • 28426314391416 ()
  • 08426314391412 ()
  • 08426314604031 ()


  • Compounding transfer set
  • Intravenous administration bag/bottle
TEKTONA HV US Bone Cement is indicated for the treatment of pathological fractures of the vertebral body using a vertebroplasty or kyphoplasty procedure. TEKTONA HV US Bone Cement is a closed sysyem which containes the powder and liquid components separately. The device is disposable and sterile.
TECRES SPA
TEK-BC HV US-S
In Commercial Distribution

  • 08031497003351 ()


  • Orthopaedic cement preparation/delivery kit
The CompressAR Jumbo SuperComfort Disc is a sterile, single use product that is attached to the CompressAR System Stand to apply compression to the femoral artery during hemostasis. The Model 5305 is a jumbo sized round disc with upturned edges and an elastomeric center (2.625" dia.).
Semler Technologies, Inc.
5305
In Commercial Distribution

  • 10815614020248 ()
  • 20815614020245 ()
  • 30815614020242 ()
150-0305-06

  • Femoral artery compression system, manual, single-use
The CompressAR Large SuperComfort Disc is a sterile, single use product that is attached to the CompressAR System Stand to apply compression to the femoral artery during hemostasis. The Model 5303 is a large sized round disc with upturned edges and an elastomeric center (2" dia.).
Semler Technologies, Inc.
5303
In Commercial Distribution

  • 10815614020231 ()
  • 20815614020238 ()
  • 30815614020235 ()
150-0303-06

  • Femoral artery compression system, manual, single-use
The S-Mono is intended to use in the treatment of missing mandibular central and lateral incisors to support prosthetic device, such as artificial teeth, in order to restore chewing function in partially edentulous patients. S-Mono is intended for single use only. It is not for immediate loading.
Shinhung MST Co., Ltd.
MB3013LR
In Commercial Distribution

  • 08806343919861 ()


  • Screw endosteal dental implant, one-piece
The S-Mono is intended to use in the treatment of missing mandibular central and lateral incisors to support prosthetic device, such as artificial teeth, in order to restore chewing function in partially edentulous patients. S-Mono is intended for single use only. It is not for immediate loading.
Shinhung MST Co., Ltd.
MB3011LR
In Commercial Distribution

  • 08806343919854 ()


  • Screw endosteal dental implant, one-piece
The S-Mono is intended to use in the treatment of missing mandibular central and lateral incisors to support prosthetic device, such as artificial teeth, in order to restore chewing function in partially edentulous patients. S-Mono is intended for single use only. It is not for immediate loading.
Shinhung MST Co., Ltd.
MB3010LR
In Commercial Distribution

  • 08806343919847 ()


  • Screw endosteal dental implant, one-piece
The S-Mono is intended to use in the treatment of missing mandibular central and lateral incisors to support prosthetic device, such as artificial teeth, in order to restore chewing function in partially edentulous patients. S-Mono is intended for single use only. It is not for immediate loading.
Shinhung MST Co., Ltd.
MB3008LR
In Commercial Distribution

  • 08806343919830 ()


  • Screw endosteal dental implant, one-piece
The S-Mono is intended to use in the treatment of missing mandibular central and lateral incisors to support prosthetic device, such as artificial teeth, in order to restore chewing function in partially edentulous patients. S-Mono is intended for single use only. It is not for immediate loading.
Shinhung MST Co., Ltd.
MB3013SR
In Commercial Distribution

  • 08806343919823 ()


  • Screw endosteal dental implant, one-piece
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