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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 is a surgical drill for dental implants used to install dental implant fixtures. It is used when performing initial drilling.
Shinhung MST Co., Ltd.
GID2604
In Commercial Distribution

  • 08806343924513 ()


  • Fixture/appliance dental drill bit, reusable
The cart (trolley) is a Non-Metallic 3 shelf mobile equipment cart, is used for transporting the Heidelberg pH Capsule systems devices.
Heidelberg Medical Inc
Heidelberg System Equipment Cart
In Commercial Distribution

  • B989EC1150 ()
EC115

  • Utility trolley
Bone carrier is used during surgery to hold Bone for grafting whilst the bone is being carried to the oral cavity
Suncoast Dental, Inc
Bone Carrier
In Commercial Distribution

  • 00083208130090 ()
Bone Carrier

  • Bone holding forceps
VIDAS ® C. difficile GDH is is a qualitative test for use on VIDAS family instruments to detect C. difficile antigen
BIOMERIEUX SA
30125-01
In Commercial Distribution

  • 03573026444204 ()


  • Clostridium difficile antigen IVD, antibody
Precedent® is intended for use as an orthodontic band cement. This is the 100g Precedent Powder. This product contains Fluoride.
RELIANCE ORTHODONTIC PRODUCTS INC
PRP100
In Commercial Distribution

  • D798PRP1000 ()
PRP100

  • Glass ionomer dental cement
GoTo™ is intended for use as a light cure bracket adhesive. This is a 4gm bag of 10 x tips.
RELIANCE ORTHODONTIC PRODUCTS INC
GTT
In Commercial Distribution

  • D798GTT1 ()
  • D798GTT0 ()
GTT

  • Orthodontic bracket adhesive
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix. Paste / Liquid. 30 Part B Carpules, bagged.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 67-028 N
In Commercial Distribution

  • D801SP67028N1 ()
67-028

  • Dentine adhesive
Capture-P solid phase system is intended for use in the detection of antibodies to platelets. This is the single microplate product.
IMMUCOR, INC.
0066246
In Commercial Distribution

  • 10888234001270 ()
0066246

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, kit, agglutination
This is a surgical drill for dental implants used to install dental implant fixtures. It is used when performing initial drilling.
Shinhung MST Co., Ltd.
GID2605
In Commercial Distribution

  • 08806343924063 ()


  • Fixture/appliance dental drill bit, reusable
Protective cover is placed on a flat panel sensor (DR-ID 1836SE) during recumbent exposure and is covered to reinforce the strength.
FUJIFILM CORPORATION
DR1836 SE PROTECTIVE COVER E
In Commercial Distribution

  • 04547410483437 ()

  • 470x860x25mm


  • Stationary basic diagnostic x-ray system, digital
The NeoBar is intended to secure an endotracheal tube. It is intended for use on pediatric (neonates, infants and children) patients.
Neotech Products LLC
Assorted
In Commercial Distribution

  • 00812594010118 ()
  • 00812594011849 ()
N719N

  • Endotracheal tube holder
The NeoBar is intended to secure an endotracheal tube. It is intended for use on pediatric (neonates, infants and children) patients.
Neotech Products LLC
Neobar Transport Box
In Commercial Distribution

  • 00812594010118 ()
  • 00812594011832 ()
N718

  • Endotracheal tube holder
Cadence Tibial Impactor Handle is attached to the Tibial Impactor Tip which is used in the insertion of the Tibial Tray.
Ascension Orthopedics, Inc.
10203137
In Commercial Distribution

  • 10381780356301 ()

  • 5.16in Lx .425in diameter
10203137

  • Joint prosthesis implantation kit, reusable
The locking screw is made from stainless steel and is used in conjunction with the Integra Proximal Humeral Fracture Plate System.
Ascension Orthopedics, Inc.
PSS3575LS
In Commercial Distribution

  • 10381780121251 ()
  • M269PSS3575LS1 ()

  • 3.061 in L x .138 in dia
PSS3575LS

  • Surgical soft-tissue manipulation forceps, alligator, reusable
The locking screw is made from stainless steel and is used in conjunction with the Integra Proximal Humeral Fracture Plate System.
Ascension Orthopedics, Inc.
PSS3570LS
In Commercial Distribution

  • M269PSS3570LS1 ()
  • 10381780121244 ()

  • 2.864 in L x .138 in dia
PSS3570LS

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The locking screw is made from stainless steel and is used in conjunction with the Integra Proximal Humeral Fracture Plate System.
Ascension Orthopedics, Inc.
PSS3565LS
In Commercial Distribution

  • M269PSS3565LS1 ()
  • 10381780121237 ()

  • 2.667 in L x .138 in dia
PSS3565LS

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The locking screw is made from stainless steel and is used in conjunction with the Integra Proximal Humeral Fracture Plate System.
Ascension Orthopedics, Inc.
PSS3560LS
In Commercial Distribution

  • M269PSS3560LS1 ()
  • 10381780121220 ()

  • 2.470 in L x .138 in dia
PSS3560LS

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The locking screw is made from stainless steel and is used in conjunction with the Integra Proximal Humeral Fracture Plate System.
Ascension Orthopedics, Inc.
PSS3555LS
In Commercial Distribution

  • M269PSS3555LS1 ()
  • 10381780121213 ()

  • 2.273 in L x .138 in dia
PSS3555LS

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The locking screw is made from stainless steel and is used in conjunction with the Integra Proximal Humeral Fracture Plate System.
Ascension Orthopedics, Inc.
PSS3550LS
In Commercial Distribution

  • M269PSS3550LS1 ()
  • 10381780121206 ()

  • 2.077 in L x .138 in dia
PSS3550LS

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The locking screw is made from stainless steel and is used in conjunction with the Integra Proximal Humeral Fracture Plate System.
Ascension Orthopedics, Inc.
PSS3545LS
In Commercial Distribution

  • M269PSS3545LS1 ()
  • 10381780121190 ()

  • 1.880 in L x .138 in dia
PSS3545LS

  • Surgical soft-tissue manipulation forceps, alligator, reusable
The locking screw is made from stainless steel and is used in conjunction with the Integra Proximal Humeral Fracture Plate System.
Ascension Orthopedics, Inc.
PSS3540LS
In Commercial Distribution

  • M269PSS3540LS1 ()
  • 10381780121183 ()

  • 1.683 in L x .138 in dia
PSS3540LS

  • Surgical soft-tissue manipulation forceps, alligator, reusable
The locking screw is made from stainless steel and is used in conjunction with the Integra Proximal Humeral Fracture Plate System.
Ascension Orthopedics, Inc.
PSS3537LS
In Commercial Distribution

  • M269PSS3537LS1 ()
  • 10381780121176 ()

  • 1.584 in L x .138 in dia
PSS3537LS

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The locking screw is made from stainless steel and is used in conjunction with the Integra Proximal Humeral Fracture Plate System.
Ascension Orthopedics, Inc.
PSS3535LS
In Commercial Distribution

  • M269PSS3535LS1 ()
  • 10381780121169 ()

  • 1.486 in L x .138 in dia
PSS3535LS

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The locking screw is made from stainless steel and is used in conjunction with the Integra Proximal Humeral Fracture Plate System.
Ascension Orthopedics, Inc.
PSS3532LS
In Commercial Distribution

  • M269PSS3532LS1 ()
  • 10381780121152 ()

  • 1.388 in L x .138 in dia
PSS3532LS

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The locking screw is made from stainless steel and is used in conjunction with the Integra Proximal Humeral Fracture Plate System.
Ascension Orthopedics, Inc.
PSS3530LS
In Commercial Distribution

  • M269PSS3530LS1 ()
  • 10381780121145 ()

  • 1.289 in L x .138 in dia
PSS3530LS

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The locking screw is made from stainless steel and is used in conjunction with the Integra Proximal Humeral Fracture Plate System.
Ascension Orthopedics, Inc.
PSS3527LS
In Commercial Distribution

  • M269PSS3527LS1 ()
  • 10381780121138 ()

  • 1.191 in L x .138 in dia
PSS3527LS

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The locking screw is made from stainless steel and is used in conjunction with the Integra Proximal Humeral Fracture Plate System.
Ascension Orthopedics, Inc.
PSS3525LS
In Commercial Distribution

  • M269PSS3525LS1 ()
  • 10381780121121 ()

  • 1.092 in L x .138 in dia
PSS3525LS

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The locking screw is made from stainless steel and is used in conjunction with the Integra Proximal Humeral Fracture Plate System.
Ascension Orthopedics, Inc.
PSS3522LS
In Commercial Distribution

  • M269PSS3522LS1 ()
  • 10381780121114 ()

  • .994 in L x .138 in dia
PSS3522LS

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The locking screw is made from stainless steel and is used in conjunction with the Integra Proximal Humeral Fracture Plate System.
Ascension Orthopedics, Inc.
PSS3520LS
In Commercial Distribution

  • M269PSS3520LS1 ()
  • 10381780121107 ()

  • .895 in L x .138 in dia
PSS3520LS

  • Surgical soft-tissue manipulation forceps, alligator, reusable
The locking screw is made from stainless steel and is used in conjunction with the Integra Proximal Humeral Fracture Plate System.
Ascension Orthopedics, Inc.
PSS3517LS
In Commercial Distribution

  • M269PSS3517LS1 ()
  • 10381780121091 ()

  • .797 in L x .138 in dia
PSS3517LS

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
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