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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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Nautical Blue Polymer - D85127

Tinted Opaque Powder
JBC and Company
27
In Commercial Distribution

  • D85127 ()
27

  • Dental appliance fabrication material, resin

3M™ ESPE™ - 30605861025059

3M™ ESPE™ Adult Anterior Polycarbonate Replacement Crown, Upper Left Laterals, Size 27, 27
3M COMPANY
27
In Commercial Distribution

  • 50605861025053 ()
  • 30605861025059 ()
  • 00605861022132 ()
27

  • Preformed dental crown, temporary

Nexpowder - 08800038405325

Nexpowder is used for hemostasis of nonvariceal gastrointestinal bleeding.
NEXTBIOMEDICAL CO., LTD.
NHS01
In Commercial Distribution

  • 08800038405325 ()
  • 18800038405322 ()
  • 28800038405329 ()


  • Non-organic haemostatic agent

BENCO - 00366975004338

#90 White .02 Taper Benco Dental Gutta Percha Points 28mm Spill Proof Pack of 120
BENCO DENTAL SUPPLY CO.
3364-478
In Commercial Distribution

  • 00366975004338 ()


  • Natural gutta-percha

X-CUBE 90 - 08800013541000

The X-CUBE 90 diagnostic ultrasound system is intended for use by, or by the order of, and under the supervision of, a licensed physician who is qualified for the evaluation of soft tissue and blood flow in the clinical applications of Fetal; Abdominal(renal & GYN/pelvic); Pediatric; Small Organ(breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Trans-rectal; Trans-vaginal; Musculo-skeletal(Conventional); Musculo-skeletal(Superficial); Cardiac(adult& pediatric); Peripheral Vessel(PV); and Urology(including prostate). And, in the imaging modes of 2D(B) mode; Harmonic mode(HAR); M mode; Color M mode; Anatomical M mode; Color Flow Doppler(CF) Mode; Power Doppler(PD) Mode; Directional PD mode; Pulsed Wave Doppler(PWD) Mode; Continuous Wave Doppler(CWD) Mode; High PRF Doppler mode; Tissue Doppler Imaging(TDI) Mode; 3D/4D mode. The X-CUBE 90 is intended to be used in a hospital or medical clinic.
Alpinion Medical Systems Co., Ltd.
X-CUBE 90
In Commercial Distribution

  • 08800013541000 ()


  • General-purpose ultrasound imaging system

Hu-Friedy Mfg. Co., LLC - 10889950002015

3-0 BLACK SILK SUTURE 27", D-14 NEEDLE 17.5MM, 1/2 CIRCLE CUTTING END TAPER
HU-FRIEDY MFG. CO., LLC
PSN953S
In Commercial Distribution

  • 10889950000905 ()
  • 10889950002015 ()

  • 3-0
PSN953S

  • Silk suture

Hu-Friedy Mfg. Co., LLC - 10889950002008

4-0 BLACK SILK SUTURE 27", D-14 NEEDLE 17.5MM, 1/2 CIRCLE CUTTING END TAPER
HU-FRIEDY MFG. CO., LLC
PSN952S
In Commercial Distribution

  • 10889950000899 ()
  • 10889950002008 ()

  • 4-0
PSN952S

  • Silk suture

Hu-Friedy Mfg. Co., LLC - 10889950001643

3-0 GREEN POLYESTER SUTURE 27", D-14 NEEDLE 17.5MM, 1/2 CIRCLE CUTTING END TAPER
HU-FRIEDY MFG. CO., LLC
PSN6953L
In Commercial Distribution

  • 10889950000530 ()
  • 10889950001643 ()

  • 3-0
PSN6953L

  • Polyester suture, non-bioabsorbable, multifilament

Hu-Friedy Mfg. Co., LLC - 10889950001445

5-0 UNDYED PGAFA SUTURE 27", C-6 NEEDLE 18.7 MM, 3/8 CIRCLE REVERSE CUT
HU-FRIEDY MFG. CO., LLC
PSN530FA
In Commercial Distribution

  • 10889950000332 ()
  • 10889950001445 ()

  • 5-0
PSN530FA

  • Polyester suture, bioabsorbable, multifilament, non-antimicrobial

Hu-Friedy Mfg. Co., LLC - 10889950001162

4-0 VIOLET PGA SUTURE 27", D-14 NEEDLE 17.5MM, 1/2 CIRCLE CUTTING END TAPER
HU-FRIEDY MFG. CO., LLC
PSN271V
In Commercial Distribution

  • 10889950000059 ()
  • 10889950001162 ()

  • 4-0
PSN271V

  • Polyester suture, bioabsorbable, multifilament, non-antimicrobial

PremierPro - 00811220032135

Warming Blanket Machine Trolley Stand w/Basket
SVS LLC
3879
In Commercial Distribution

  • 00811220032135 ()
3879

  • Blanket warming cabinet, dry-heat

PremierPro - 00811220032111

Warming Blanket HEPA Filter, 1/cs
SVS LLC
3877
In Commercial Distribution

  • 00811220032111 ()
3877

  • Blanket warming cabinet, dry-heat

PremierPro - 00811220032104

Warming Blanket Warming Machine, 1/cs The Warming System is indicated for hyper or hypothermic patients or normothermic patients for who induced hyper or hypothermia or localized temperature therapy is clinically indicated. In addition, the Warming System can be used to provide patient thermal comfort when conditions exist that may cause patients to become too cold or too warm.
SVS LLC
3875
In Commercial Distribution

  • 00811220032104 ()
3875

  • Blanket warming cabinet, dry-heat

PremierPro - 00811220032098

Warming Blanket, Pre Warming Gown, Size Small plus Kit 1. GENERAL DESCRIPTION · PremierPro™ Multi-functional Warming Blankets 2. CONSTRUCTION · Raw material: Multi-Laminate/ Heat Sealed or Stitched Non-woven Polypropylene fabric · Yellow / Non-Breathable Air Capture Layer – Coated / Low-density polyethylene (LDPE) · White (patient facing) Layer - Perforated to enable passage of air and temperature control · Disposable / Single Patient Use · Not made with natural rubber latex. 3. MRI COMPATIBLE · Non-Metallic / Disposable Patient Warming Blankets are compatible with Magnetic Resonance Imaging equipment The Warming System is indicated for hyper or hypothermic patients or normothermic patients for who induced hyper or hypothermia or localized temperature therapy is clinically indicated. In addition, the Warming System can be used to provide patient thermal comfort when conditions exist that may cause patients to become too cold or too warm.
SVS LLC
3869
In Commercial Distribution

  • 00811220032098 ()
  • 10811220032095 ()
3869

  • Blanket warming cabinet, dry-heat

PremierPro - 00811220032081

Warming Blanket, Pre Warming Gown, Size Medium plus Kit 1. GENERAL DESCRIPTION · PremierPro™ Multi-functional Warming Blankets 2. CONSTRUCTION · Raw material: Multi-Laminate/ Heat Sealed or Stitched Non-woven Polypropylene fabric · Yellow / Non-Breathable Air Capture Layer – Coated / Low-density polyethylene (LDPE) · White (patient facing) Layer - Perforated to enable passage of air and temperature control · Disposable / Single Patient Use · Not made with natural rubber latex. 3. MRI COMPATIBLE · Non-Metallic / Disposable Patient Warming Blankets are compatible with Magnetic Resonance Imaging equipment The Warming System is indicated for hyper or hypothermic patients or normothermic patients for who induced hyper or hypothermia or localized temperature therapy is clinically indicated. In addition, the Warming System can be used to provide patient thermal comfort when conditions exist that may cause patients to become too cold or too warm.
SVS LLC
3868
In Commercial Distribution

  • 10811220032088 ()
  • 00811220032081 ()
3868

  • Blanket warming cabinet, dry-heat

PremierPro - 00811220032074

Warming Blanket, Pre Warming Gown, Size Large plus Kit 1. GENERAL DESCRIPTION · PremierPro™ Multi-functional Warming Blankets 2. CONSTRUCTION · Raw material: Multi-Laminate/ Heat Sealed or Stitched Non-woven Polypropylene fabric · Yellow / Non-Breathable Air Capture Layer – Coated / Low-density polyethylene (LDPE) · White (patient facing) Layer - Perforated to enable passage of air and temperature control · Disposable / Single Patient Use · Not made with natural rubber latex. 3. MRI COMPATIBLE · Non-Metallic / Disposable Patient Warming Blankets are compatible with Magnetic Resonance Imaging equipment The Warming System is indicated for hyper or hypothermic patients or normothermic patients for who induced hyper or hypothermia or localized temperature therapy is clinically indicated. In addition, the Warming System can be used to provide patient thermal comfort when conditions exist that may cause patients to become too cold or too warm.
SVS LLC
3867
In Commercial Distribution

  • 10811220032071 ()
  • 00811220032074 ()
3867

  • Blanket warming cabinet, dry-heat

PremierPro - 00811220032067

Warming Blanket, Pre Warming Gown, Size XL plus Kit 1. GENERAL DESCRIPTION · PremierPro™ Multi-functional Warming Blankets 2. CONSTRUCTION · Raw material: Multi-Laminate/ Heat Sealed or Stitched Non-woven Polypropylene fabric · Yellow / Non-Breathable Air Capture Layer – Coated / Low-density polyethylene (LDPE) · White (patient facing) Layer - Perforated to enable passage of air and temperature control · Disposable / Single Patient Use · Not made with natural rubber latex. 3. MRI COMPATIBLE · Non-Metallic / Disposable Patient Warming Blankets are compatible with Magnetic Resonance Imaging equipment The Warming System is indicated for hyper or hypothermic patients or normothermic patients for who induced hyper or hypothermia or localized temperature therapy is clinically indicated. In addition, the Warming System can be used to provide patient thermal comfort when conditions exist that may cause patients to become too cold or too warm.
SVS LLC
3866
In Commercial Distribution

  • 10811220032064 ()
  • 00811220032067 ()
3866

  • Blanket warming cabinet, dry-heat

PremierPro - 00811220032050

Warming Blanket, Pre Warming Gown, Size Small 1. GENERAL DESCRIPTION · PremierPro™ Multi-functional Warming Blankets 2. CONSTRUCTION · Raw material: Multi-Laminate/ Heat Sealed or Stitched Non-woven Polypropylene fabric · Yellow / Non-Breathable Air Capture Layer – Coated / Low-density polyethylene (LDPE) · White (patient facing) Layer - Perforated to enable passage of air and temperature control · Disposable / Single Patient Use · Not made with natural rubber latex. 3. MRI COMPATIBLE · Non-Metallic / Disposable Patient Warming Blankets are compatible with Magnetic Resonance Imaging equipment The Warming System is indicated for hyper or hypothermic patients or normothermic patients for who induced hyper or hypothermia or localized temperature therapy is clinically indicated. In addition, the Warming System can be used to provide patient thermal comfort when conditions exist that may cause patients to become too cold or too warm.
SVS LLC
3863
In Commercial Distribution

  • 10811220032057 ()
  • 00811220032050 ()
3863

  • Blanket warming cabinet, dry-heat

PremierPro - 00811220032043

Warming Blanket, Pre Warming Gown, Size Medium 1. GENERAL DESCRIPTION · PremierPro™ Multi-functional Warming Blankets 2. CONSTRUCTION · Raw material: Multi-Laminate/ Heat Sealed or Stitched Non-woven Polypropylene fabric · Yellow / Non-Breathable Air Capture Layer – Coated / Low-density polyethylene (LDPE) · White (patient facing) Layer - Perforated to enable passage of air and temperature control · Disposable / Single Patient Use · Not made with natural rubber latex. 3. MRI COMPATIBLE · Non-Metallic / Disposable Patient Warming Blankets are compatible with Magnetic Resonance Imaging equipment The Warming System is indicated for hyper or hypothermic patients or normothermic patients for who induced hyper or hypothermia or localized temperature therapy is clinically indicated. In addition, the Warming System can be used to provide patient thermal comfort when conditions exist that may cause patients to become too cold or too warm.
SVS LLC
3862
In Commercial Distribution

  • 10811220032040 ()
  • 00811220032043 ()
3862

  • Blanket warming cabinet, dry-heat

PremierPro - 00811220032036

Warming Blanket, Pre Warming Gown, Size Large 1. GENERAL DESCRIPTION · PremierPro™ Multi-functional Warming Blankets 2. CONSTRUCTION · Raw material: Multi-Laminate/ Heat Sealed or Stitched Non-woven Polypropylene fabric · Yellow / Non-Breathable Air Capture Layer – Coated / Low-density polyethylene (LDPE) · White (patient facing) Layer - Perforated to enable passage of air and temperature control · Disposable / Single Patient Use · Not made with natural rubber latex. 3. MRI COMPATIBLE · Non-Metallic / Disposable Patient Warming Blankets are compatible with Magnetic Resonance Imaging equipment The Warming System is indicated for hyper or hypothermic patients or normothermic patients for who induced hyper or hypothermia or localized temperature therapy is clinically indicated. In addition, the Warming System can be used to provide patient thermal comfort when conditions exist that may cause patients to become too cold or too warm.
SVS LLC
3861
In Commercial Distribution

  • 10811220032033 ()
  • 00811220032036 ()
3861

  • Blanket warming cabinet, dry-heat
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