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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Tinto Toxoplasma gondii is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 15 ml
In Commercial Distribution

  • B502BSB60450 ()
BSB 6045

  • Toxoplasma gondii immunoglobulin A (IgA)/IgG/IgM antibody IVD, control
Tinto Toxoplasma gondii is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 7 ml
In Commercial Distribution

  • B502BSB60440 ()
BSB 6044

  • Toxoplasma gondii immunoglobulin A (IgA)/IgG/IgM antibody IVD, control
Tinto Toxoplasma gondii is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 3 ml
In Commercial Distribution

  • B502BSB60430 ()
BSB 6043

  • Toxoplasma gondii immunoglobulin A (IgA)/IgG/IgM antibody IVD, control
Myelin Basic Protein is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 1 ml
In Commercial Distribution

  • B502BSB57830 ()
BSB 5783

  • Myelin basic protein IVD, antibody
Myelin Basic Protein is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 0.5 ml
In Commercial Distribution

  • B502BSB57820 ()
BSB 5782

  • Myelin basic protein IVD, antibody
Myelin Basic Protein is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 0.1 ml
In Commercial Distribution

  • B502BSB57810 ()
BSB 5781

  • Myelin basic protein IVD, antibody
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
The hex post is used to connect and support rings in the construct. The hex post is made from stainless steel.
Ascension Orthopedics, Inc.
12224212
In Commercial Distribution

  • 10381780125303 ()

  • 60 mm L
12224212

  • External orthopaedic fixation system, reusable
The hex post is used to connect and support rings in the construct. The hex post is made from stainless steel.
Ascension Orthopedics, Inc.
12224211
In Commercial Distribution

  • 10381780125297 ()

  • 40 mm L
12224211

  • External orthopaedic fixation system, reusable
The hex post is used to connect and support rings in the construct. The hex post is made from stainless steel.
Ascension Orthopedics, Inc.
12224210
In Commercial Distribution

  • 10381780125280 ()

  • 20 mm L
12224210

  • External orthopaedic fixation system, reusable
The angular half pin fixation clamp is made from stainless steel and is used to connect half pins to the rings.
Ascension Orthopedics, Inc.
12225010
In Commercial Distribution

  • 10381780125273 ()

  • .97 in L x .846 in W; .394 in taper
12225010

  • External orthopaedic fixation system, 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
The locking screw is made from stainless steel and is used in conjunction with the Integra Proximal Humeral Fracture Plate System.
Ascension Orthopedics, Inc.
PSS3515LS
In Commercial Distribution

  • M269PSS3515LS1 ()
  • 10381780121084 ()

  • .699 in L x .138 in dia
PSS3515LS

  • 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.
PSS2725LS
In Commercial Distribution

  • M269PSS2725LS1 ()
  • 10381780120964 ()

  • 1.126 in L x .106 in dia
PSS2725LS

  • 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.
PSS2722LS
In Commercial Distribution

  • M269PSS2722LS1 ()
  • 10381780120957 ()

  • 1.028 in L x .106 in dia
PSS2722LS

  • 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.
PSS2720LS
In Commercial Distribution

  • M269PSS2720LS1 ()
  • 10381780120940 ()

  • .929 in L x .106 in dia
PSS2720LS

  • 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.
PSS2717LS
In Commercial Distribution

  • M269PSS2717LS1 ()
  • 10381780120933 ()

  • .800 in L x .106 in dia
PSS2717LS

  • 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.
PSS2715LS
In Commercial Distribution

  • M269PSS2715LS1 ()
  • 10381780120926 ()

  • .733 in L x .106 in dia
PSS2715LS

  • 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.
PSS2712LS
In Commercial Distribution

  • M269PSS2712LS1 ()
  • 10381780120919 ()

  • .634 in L x .106 in dia
PSS2712LS

  • 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.
PSS2710LS
In Commercial Distribution

  • 10381780120902 ()
  • M269PSS2710LS1 ()

  • .536 in L x .106 in dia
PSS2710LS

  • Surgical soft-tissue manipulation forceps, alligator, reusable
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
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
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 rechargeable Li-Ion replacement battery for the NIOX VERO that is charged via the power supply or USB port.
Circassia AB
VERO Battery
In Commercial Distribution

  • 07350047030366 ()
12-1150

  • Nitrogen monoxide analyser
Tinto Helicobacter Pylori is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 15 ml
In Commercial Distribution

  • B502BSB32810 ()
BSB 3281

  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, reagent
Tinto Helicobacter Pylori is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 7 ml
In Commercial Distribution

  • B502BSB32800 ()
BSB 3280

  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, reagent
Tinto Helicobacter Pylori is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 3 ml
In Commercial Distribution

  • B502BSB32790 ()
BSB 3279

  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, reagent
Capo Universal is a light-curing composite containing an ultrafine, radiopaque glass filler and is indicated for placing fillings using adhesive techniques.
Schütz Dental GmbH
232054
In Commercial Distribution

  • ESDG2320541 ()


  • Dental composite resin
Jointown Surigcal Face Mask is a class II medical device (product code FXX). It is a ASTM level 2 facemask. The smallest packaging unit with UDI is a paper box containing 50 pieces.
U.S. HEALTH EXPRESS CORP.
2082Blue
In Commercial Distribution

  • 00850017230026 ()
  • 00850017230002 ()
2082

  • Surgical/medical face mask, single-use
The Etchmaster system is intended for use is for polishing, roughening and/or etching of tooth surfaces, enamel, dentin, and dental restorations for adhesive restorative procedures. This is the Etchmaster Regular Tip, Large
RELIANCE ORTHODONTIC PRODUCTS INC
EMTRL
In Commercial Distribution

  • D798EMTRL1 ()
  • D798EMTRL0 ()
EMTRL

  • Dental abrasive air jet system
Trel-XPress 300, 2.5cc is made using demineralized human bone mixed with poloxamer resorbable reverse phase medium. Trel-Xpress 300 is formulated into a putty form and is provided in a sterile, single use package.
Integra Lifesciences Corporation
XPRES325
In Commercial Distribution

  • M386XPRES3251 ()
  • 10381780112563 ()

  • 2.5cc
XPRES325

  • Bone matrix implant, human-derived
Trel-XPress 300, 5cc is made using demineralized human bone mixed with poloxamer resorbable reverse phase medium. Trel-Xpress 300 is formulated into a putty form and is provided in a sterile, single use package.
Integra Lifesciences Corporation
XPRES305
In Commercial Distribution

  • M386XPRES3051 ()
  • 10381780112556 ()

  • 5cc
XPRES305

  • Bone matrix implant, human-derived
Trel-XPress 300, 10cc is made using demineralized human bone mixed with poloxamer resorbable reverse phase medium. Trel-Xpress 300 is formulated into a putty form and is provided in a sterile, single use package.
Integra Lifesciences Corporation
XPRES310
In Commercial Distribution

  • 10381780112549 ()
  • M386XPRES3101 ()

  • 10cc
XPRES310

  • Bone matrix implant, human-derived
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