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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The TriNEST™ microplate incubator and shaker is intended for use in laboratories where incubation and shaking of microplates is needed.
Wallac Oy
1296-0050
In Commercial Distribution

  • 06438147297726 ()
1296-0050

  • Laboratory shaker IVD
The Universal Legholder is contoured and padded for comfortable leg support, and is mounted on a ball joint for positioning flexibility.
STERIS CORPORATION
BF266
In Commercial Distribution

  • 00724995156985 ()
BF266

  • Leg procedure positioner
The Torrent irrigation pump is used to provide irrigation in endoscopic procedures. This product is used exclusively for our loaner program.
US Endoscopy
00711579
In Commercial Distribution

00711579

  • Surgical irrigation pump
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
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
The Lightweight Vest is designed to carry a CADD-Legacy® 1400 pump. This Lightweight Vest is intended for single-patient use only.
ABBVIE INC.
10634
In Commercial Distribution

  • 38054083008203 ()
  • 08054083008202 ()


  • Personal device holder, reusable
The Lightweight Vest is designed to carry a CADD-Legacy® 1400 pump. This Lightweight Vest is intended for single-patient use only.
ABBVIE INC.
10634
In Commercial Distribution

  • 38054083008197 ()
  • 08054083008196 ()


  • Personal device holder, reusable
The Lightweight Vest is designed to carry a CADD-Legacy® 1400 pump. This Lightweight Vest is intended for single-patient use only.
ABBVIE INC.
10634
In Commercial Distribution

  • 38054083008180 ()
  • 08054083008189 ()


  • Personal device holder, reusable
The Lightweight Vest is designed to carry a CADD-Legacy® 1400 pump. This Lightweight Vest is intended for single-patient use only.
ABBVIE INC.
10634
In Commercial Distribution

  • 38054083008173 ()
  • 08054083008172 ()


  • Personal device holder, reusable
The Lightweight Vest is designed to carry a CADD-Legacy® 1400 pump. This Lightweight Vest is intended for single-patient use only.
ABBVIE INC.
10634
In Commercial Distribution

  • 38054083008227 ()
  • 08054083008226 ()


  • Personal device holder, reusable
The Lightweight Vest is designed to carry a CADD-Legacy® 1400 pump. This Lightweight Vest is intended for single-patient use only.
ABBVIE INC.
10634
In Commercial Distribution

  • 38054083008210 ()
  • 08054083008219 ()


  • Personal device holder, reusable
Retainium is intended for use as a lingual retention wire. This is a single strand for sample evaluation. 0.016 mm Diameter
RELIANCE ORTHODONTIC PRODUCTS INC
XLRETSAM
In Commercial Distribution

  • D798XLRETSAM0 ()
XLRETSAM

  • Orthodontic retainer
Ultra Band-Lok® is intended for use as an orthodontic band cement and for occlusal buildups. This product is natural shade.
RELIANCE ORTHODONTIC PRODUCTS INC
UBLPP
In Commercial Distribution

  • D798UBLPP0 ()
UBLPP

  • Dental composite resin
Ultra Band-Lok® is intended for use as an orthodontic band cement and for occlusal buildups. This product is blue shade.
RELIANCE ORTHODONTIC PRODUCTS INC
UBLBPP
In Commercial Distribution

  • D798UBLBPP0 ()
UBLBPP

  • Dental composite resin
Ultra Band-Lok® is intended for use as an orthodontic band cement and for occlusal buildups. This kit is blue shade.
RELIANCE ORTHODONTIC PRODUCTS INC
UBLB
Not in Commercial Distribution

  • D798UBLB0 ()
UBLB

  • Dental composite resin
Ultra Band-Lok® is intended for use as an orthodontic band cement and for occlusal buildups. This kit is Natural Shade
RELIANCE ORTHODONTIC PRODUCTS INC
UBL
Not in Commercial Distribution

  • D798UBL0 ()
UBL

  • Dental composite resin
The Syringe, 10 mL is a component of the COBRA-OS™ Kit and is used to inflate the COBRA-OS™ balloon.
Front Line Medical Technologies Inc.
E01P3
In Commercial Distribution

  • 10628678061061 ()

  • Total Volume: 10 Milliliter
E01P3

  • General-purpose syringe, single-use
Tinto Alpha -1-Antitrypsin 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

  • B502BSB50080 ()
BSB 5008

  • Alpha-1-antitrypsin (protease inhibitor) IVD, antibody
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.
Prediluted, 7 ml
In Commercial Distribution

  • B502BSB56040 ()
BSB5604

  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, reagent
The Torrent irrigation pump is used to provide irrigation in endoscopic procedures. This product is used exclusively for our loaner program.
US Endoscopy
00711579
Not in Commercial Distribution

  • 00816765014639 ()
00711579

  • Surgical irrigation pump
Tinto FOXA1 / HNF-3A is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 15ml
In Commercial Distribution

  • B502BSB67460 ()
BSB 6746

  • Forkhead box protein (FOX) IVD, antibody
Tinto FOXA1 / HNF-3A is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 3ml
In Commercial Distribution

  • B502BSB67440 ()
BSB 6744

  • Forkhead box protein (FOX) IVD, antibody
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
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
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
Cadence Tibial Impactor Handle is attached to the Tibial Impactor Tip which is used in the insertion of the Tibial Tray.
Ascension Orthopedics, Inc.
10203136
Not in Commercial Distribution

  • M268102031361 ()
  • 10381780240303 ()

  • 5.16in Lx .425in diameter


  • Orthopaedic implant/instrument assembling device
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
Myriad Morcells™ is derived from an extracellular matrix primarily composed of ovine collagen and is supplied as a sterile particulate.
AROA BIOSURGERY LIMITED
PW01NA1000
In Commercial Distribution

  • 09421905067928 ()

  • Weight: 1000 Milligram


  • Animal-derived wound matrix dressing
Myriad Morcells™ is derived from an extracellular matrix primarily composed of ovine collagen and is supplied as a sterile particulate.
AROA BIOSURGERY LIMITED
PW01NA0500
In Commercial Distribution

  • 09421905067911 ()

  • Weight: 500 Milligram


  • Animal-derived wound matrix dressing
Myriad Morcells™ is derived from an extracellular matrix primarily composed of ovine collagen and is supplied as a sterile particulate.
AROA BIOSURGERY LIMITED
PW02NA0050
In Commercial Distribution

  • 09421906017977 ()

  • Weight: 50 Milligram


  • Animal-derived wound matrix dressing
Myriad Morcells™ is derived from an extracellular matrix primarily composed of ovine collagen and is supplied as a sterile particulate.
AROA BIOSURGERY LIMITED
PW02NA0100
In Commercial Distribution

  • 09421906017960 ()

  • Weight: 100 Milligram


  • Animal-derived wound matrix dressing
Myriad Morcells™ is derived from an extracellular matrix primarily composed of ovine collagen and is supplied as a sterile particulate.
AROA BIOSURGERY LIMITED
PW02NA0200
In Commercial Distribution

  • 09421906017953 ()

  • Weight: 200 Milligram


  • Animal-derived wound matrix dressing
Myriad Morcells™ is derived from an extracellular matrix primarily composed of ovine collagen and is supplied as a sterile particulate.
AROA BIOSURGERY LIMITED
PW02NA0500
In Commercial Distribution

  • 09421906017946 ()

  • Weight: 500 Milligram


  • Animal-derived wound matrix dressing
Myriad Morcells™ is derived from an extracellular matrix primarily composed of ovine collagen and is supplied as a sterile particulate.
AROA BIOSURGERY LIMITED
PW02NA1000
In Commercial Distribution

  • 09421906017939 ()

  • Weight: 1000 Milligram


  • Animal-derived wound matrix dressing
Myriad Morcells™ is derived from an extracellular matrix primarily composed of ovine collagen and is supplied as a sterile particulate.
AROA BIOSURGERY LIMITED
PW02NA2000
Not in Commercial Distribution

  • 09421906017922 ()

  • Weight: 2000 Milligram


  • Animal-derived wound matrix dressing
Myriad Morcells™ is derived from an extracellular matrix primarily composed of ovine collagen and is supplied as a sterile particulate.
AROA BIOSURGERY LIMITED
PW01NA2000
Not in Commercial Distribution

  • 09421906017915 ()

  • Weight: 2000 Milligram


  • Animal-derived wound matrix dressing
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
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
Mixing Tip/ Intraoral Tip is the mixing and application device to be applied with AH Plus Jet and is available seperately
Dentsply De Trey GmbH
60620116
In Commercial Distribution

  • D01060620110 ()
  • D01060620111 ()

  • Length: 5.2 Centimeter
60620116

  • Endodontic filling/sealing material
The NeoBar is intended to secure an endotracheal tube. It is intended for use on pediatric (neonates, infants and children) patients.
Neotech Products LLC
Mega Friendly Foam
In Commercial Distribution

  • 00812594011511 ()
  • 10812594011518 ()
N717F

  • Endotracheal tube holder
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