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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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Aquasil Ultra DenPlant™ Smart Wetting® Impression Material Introductory Kit
DENTSPLY INTERNATIONAL INC.
678169
Not in Commercial Distribution

  • D0026781691 ()

  • Total Volume: 50 Milliliter
  • 1 Cartridge Monophase RS, 2 Cartridges LV RS, 3 Cartridges XLV RS, 2 Cartridges Rigid FS, 24 Mixing Tips, 12 Intraoral Tips, 1 Bottle Adhesive, 1 Strong Massad DenPlant™ Tray Kit (12 trays total)
678169

  • Silicone dental impression material
Overall size 24”W x 20.5”D x 74.5”T. Upper Chamber I.D. 20”W x 17”D x 13.5”T 2.67 Cubic ft. storage. Lower chamber I.D. 20 “W x 17”D x 34.25”T 6.74 Cubic ft. storage. Digital control. Foot levelers. 3 Adjustable shelves. Stainless steel doors. Audible and visual over-temp alarm. Accuracy +/- 1 degrees F (upper chamber). Accuracy +/- 3 degrees F (lower chamber). Electrical: 120V, 15 Amp, 50/60 Hz. .75kw/hr, 2557 btu/hr. UL/CUL listed.
FUTURE HEALTH CONCEPTS, INC.
FHCDWC24-1824-TL
In Commercial Distribution

  • B337FHCDWC241824TL1 ()
FHCDWC24-1824-TL

  • Blanket warming cabinet, dry-heat
Overall size 24”W x 20.5”D x 64.75"T Upper Chamber I.D. 20”W x 17”D x 13.5”T 2.65 Cubic ft. storage. Lower chamber I.D. 20 “W x 17”D x 24.5”T 4.80 Cubic ft. storage. Digital control. 3 Adjustable shelves. Audible and visual over-temp alarm. Glass Doors Foot levelers Upper chamber door lock, Keyed temperature lock, Data logger Accuracy +/- 1 degrees F (upper chamber). Accuracy +/- 2 degrees F (lower chamber). Electrical: 220V UL/CUL listed. Mobile base
M.A.C. MEDICAL INC.
DWC182464T-G-MB-220
In Commercial Distribution

  • B286DWC182464TGMB2201 ()
DWC182464T-G-MB-220

  • Blanket warming cabinet, dry-heat
The Non-Activated Clotting Test Kit contains the necessary components for an in vitro diagnostic test for use with the Sonoclot® Coagulation & Platelet Function Analyzer System. It may be used with native whole blood, citrated whole blood, and plasma. The Non-Activated Kit may either be used as a non-activated clotting test or as a general use test with user provided activators. It is intended for customer designed hemostasis monitoring on the Sonoclot Analyzer. The Non-Activated cuvette allows for coagulation monitoring using tissue activation, thrombin activation, and other custom activators. Some of the applications for the Non-Activated test with the addition of customer determined reagents are monitoring of fibrin formation, fibrinolysis, hyperfibrinolysis and clot retraction. When used with the Sonoclot Analyzer System, the Non-Activated test provides quantitative Onset/ACT and Clot Rate results as well as qualitative and quantitative information on the Sonoclot Signature including: fibrin formation, platelet function, and hyperfibrinolysis. Each kit contains 24 lidded plastic cuvettes, 24 probes, and instructions for use. The cuvettes contain a magnetic stir bar.
SIENCO, INC.
800-0426
In Commercial Distribution

  • B55880004260 ()
  • B55880004261 ()
800-0426

  • Multiple coagulation factor IVD, kit, clotting
The gbACT+ Kit is an in vitro diagnostic reagent for use with the Sonoclot® Coagulation & Platelet Function Analyzer System. The gbACT+ test is a glass bead activated whole blood clotting time test. It may also be used with citrated whole blood and plasma. Warning: The gbACT+ test is not intended for high dose heparin management during cardiopulmonary bypass surgery. The gbACT+ Kit is intended for general purpose global hemostasis monitoring including: clot detection, fibrin formation, platelet function, and hyperfibrinolysis. The monitoring information is typically used for anticoagulant management at low to moderate heparin levels (0 to 2 units per ml), hypercoagulable and/or hypocoagulable screening, platelet function assessment, and hyperfibrinolysis screening. When used with the Sonoclot Analyzer System, the gbACT+ test provides quantitative Onset/ACT and Clot Rate results as well as qualitative and quantitative information on the Sonoclot Signature including: fibrin formation, platelet function, and hyperfibrinolysis. Each kit contains 24 lidded pink plastic activation cuvettes, 24 probes, and instructions for use. The activation cuvettes contain a controlled amount of glass beads and a magnetic stir bar.
SIENCO, INC.
800-0411
In Commercial Distribution

  • B55880004110 ()
  • B55880004111 ()
800-0411

  • Multiple coagulation factor IVD, kit, clotting
Overall size 24”W x 20.5”D x 74.5”T. Upper Chamber I.D. 20”W x 17”D x 13.5”T 2.67 Cubic ft. storage. Lower chamber I.D. 20 “W x 17”D x 34.25”T 6.74 Cubic ft. storage. Digital control. Foot levelers. 3 Adjustable shelves. Stainless steel doors. Data Logger Audible and visual over-temp alarm. Accuracy +/- 1 degrees F (upper chamber). Accuracy +/- 3 degrees F (lower chamber). Electrical: 120V, 15 Amp, 50/60 Hz. .75kw/hr, 2557 btu/hr. UL/CUL listed.
FUTURE HEALTH CONCEPTS, INC.
FHCDWC24-1824-TL-D
In Commercial Distribution

  • B337FHCDWC241824TLD1 ()
FHCDWC24-1824-TL-D

  • Blanket warming cabinet, dry-heat
Overall size 24”W x 20.5”D x 74.5”T. Upper Chamber I.D. 20”W x 17”D x 13.5”T 2.67 Cubic ft. storage. Lower chamber I.D. 20 “W x 17”D x 34.25”T 6.74 Cubic ft. storage. Digital control. Foot levelers. 3 Adjustable shelves. Stainless steel doors. Data Logger Audible and visual over-temp alarm. Accuracy +/- 1 degrees F (upper chamber). Accuracy +/- 3 degrees F (lower chamber). Electrical: 120V, 15 Amp, 50/60 Hz. .75kw/hr, 2557 btu/hr. UL/CUL listed.
M.A.C. MEDICAL INC.
FHCDWC24-1824-TL-D
In Commercial Distribution

  • B286FHCDWC241824TLD1 ()
FHCDWC24-1824-TL-D

  • Blanket warming cabinet, dry-heat
Overall size 24”W x 20.5”D x 64.75"T Upper Chamber I.D. 20”W x 17”D x 13.5”T 2.65 Cubic ft. storage. Lower chamber I.D. 20 “W x 17”D x 24.5”T 4.80 Cubic ft. storage. Digital control. 3 Adjustable shelves. Audible and visual over-temp alarm. Glass Doors Foot levelers Upper chamber door lock Keyed temperature lock Data logger 4" base Accuracy +/- 1 degrees F (upper chamber). Accuracy +/- 2 degrees F (lower chamber). Electrical: 220V UL/CUL listed. United Kingdom Plug Celcius
M.A.C. MEDICAL INC.
DWC182464T-G-4B-220UK-C
In Commercial Distribution

  • B286DWC182464TG4B220UK1 ()
DWC182464T-G-4B-220UK-C

  • Blanket warming cabinet, dry-heat
Overall size 24”W x 20.5”D x 64.75”T. 7.45 Cubic ft. storage Upper Chamber I.D. 20”W x 17”D x 13.5”T 2.65 Cubic ft. storage Temperature Range: 90-160 F Accuracy +/- 1 degrees F of set point Lower Chamber I.D. 20”W x 17”D x 24.5”T 4.8 Cubic ft. storage Temperature Range: 90-160 F Accuracy +/- 2 degrees F of set point 3 Adjustable shelves Digital control Glass doors Audible and visual over-temp alarm Foot levelers Electrical: 120V, 7.5 Amp, 50/60 Hz .49 kw/hr, 1678 btu/hr
M.A.C. MEDICAL INC.
FHCDWC2460-TL-G-D
In Commercial Distribution

  • B286FHCDWC2460TLGD1 ()
FHCDWC2460-TL-G-D

  • Blanket warming cabinet, dry-heat
Overall size 24”W x 26.5”D x 74.5”T. 15.95 Cubic ft. storage Upper Chamber I.D. 20”W x 23”D x 15.25”T 4.05 Cubic ft. storage Temperature Range: 90-160 F Accuracy +/- 1 degrees F of set point Lower Chamber I.D. 20”W x 23”D x 34.5”T 11.9 Cubic ft. storage Temperature Range: 90-160 F Accuracy +/- 3 degrees F of set point 3 Adjustable shelves Digital control Glass door Audible and visual over-temp alarm Data logger Foot levelers Electrical: 120V, 7.5 Amp, 50/60 Hz .46 kw/hr, 1570 btu/hr
M.A.C. MEDICAL INC.
FHCDWC2424-TL-G-D
In Commercial Distribution

  • B286FHCDWC2424TLGD1 ()
FHCDWC2424-TL-G-D

  • Blanket warming cabinet, dry-heat
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