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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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otosil ES-1.1 - EPRCA0031776

ES-1.1 / 40 Shore black-opaque 8 double cartridges with 48 ml each
pro3dure medical GmbH
Shore 40 / 8 double cartridges of 2 x 24 ml - black opaque
In Commercial Distribution

  • EPRCA0031776 ()
A0031776

  • Earmould, custom-made

otosil ES-1.1 - EPRCA0030203

ES-1.1 / 25 Shore reddish-transparent 8 double cartridges with 48 ml each
pro3dure medical GmbH
Shore 25 / 8 double cartridges of 2 x 24 ml - reddish transparent
In Commercial Distribution

  • EPRCA0030203 ()
A0030203

  • Earmould, custom-made

SINGLE CHAMBER WARMING CABINET - B286FHCSWC2460TLGDMB1

Overall size 24”W x 20.5”D x 64.75”T. 9.73 Cubic ft. storage Chamber I.D. 20”W x 17”D x 49.5”T. Temperature Range: 90-160 F Accuracy +/- 1 degrees F of set point 3 Adjustable shelves Digital control Glass door Audible and visual over-temp alarm Data Logger Mobile Base Electrical: 120V, 7.5 Amp, 50/60 Hz .49kw/hr, 1678 btu/hr
M.A.C. MEDICAL INC.
FHCSWC2460-TL-G-D-MB
In Commercial Distribution

  • B286FHCSWC2460TLGDMB1 ()
FHCSWC2460-TL-G-D-MB

  • Blanket warming cabinet, dry-heat

SINGLE CHAMBER WARMING CABINET GLASS DOOR - B286FHCSWC1824TSGD1

Overall size 24”W x 20.5”D x 24.5”T. 3.0 Cubic ft. storage Chamber I.D. 20”W x 17"D x 15.25”T Temperature Range: 90-160 F Accuracy +/- 1 degrees F Touch Screen Glass door Audible and visual over-temp alarm. Keyed temperature lock for each chamber Data Logger Foot levelers Electrical: 120V, 3.5 Amp, 50/60 Hz. .45kw/hr, 1537 btu/hr.
M.A.C. MEDICAL INC.
FHCSWC1824-TS-G-D
In Commercial Distribution

  • B286FHCSWC1824TSGD1 ()
FHCSWC1824-TS-G-D

  • Blanket warming cabinet, dry-heat

Integra® Ti6® Internal Fixation System - 10381780074304

The Integra Ti6 Internal Fixation System is comprised of Digital screws used for bone fixation of the hand and foot following trauma or osteotomy. The Digital Screw is a cannulated, threaded bone screw which is offered in a 2.0mm diameter with lengths of 24 to 50mm. The system includes titanium and stainless steel instruments to facilitate the placement of the screws.
Ascension Orthopedics, Inc.
TI6DIGITIMP
Not in Commercial Distribution

  • M268TI6DIGITIMP1 ()
  • 10381780074304 ()
TI6DIGITIMP

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

Aquasil Ultra Fast Set Edentulous Smart Wetting® Impression Material - D0026781771

Aquasil Ultra Fast Set Edentulous Smart Wetting® Impression Material Introductory Kit with Massad™ Edentulous Impression Trays Kit
DENTSPLY INTERNATIONAL INC.
678177
Not in Commercial Distribution

  • D0026781771 ()

  • Total Volume: 50 Milliliter
  • 2 Cartridges Monophase FS, 2 Cartridges LV FS, 2 Cartridges XLV FS, 2 Cartridges Rigid FS, 24 Mixing Tips, 1 Bottle Tray Adhesive, 1 Massad™ Edentulous Impression Trays Kit
678177

  • Silicone dental impression material

BRAEBON MediByte - B140MP8KN0

The MediByte is a portable sleep data recorder used to record physiological signals during sleep while the patient is either at home or in a clinical environment. Kit contains: 1 MediByte; 2 Q-RIP Effort Belts; 6 MediByte Electrode Prep Kits; 6 Self-Adhesive Electrodes; 1 Snore Microphone with Thermistor Input; I Electrode Box; 24" and 60" Leadwire Kit; 1 cTherm Cannula Thermistor; 1 SpO2 sensor; 1 Communication Cable;
Braebon Medical Corporation
MP8KN
In Commercial Distribution

  • B140MP8KN0 ()
MP8KN

  • Polysomnograph

SINGLE CHAMBER WARMING CABINET - B286FHCSWC2460TLDMB1

Overall size 24”W x 20.5”D x 64.75”T. 9.73 Cubic ft. storage Chamber I.D. 20”W x 17”D x 49.5”T. Temperature Range: 90-160 F Accuracy +/- 1 degrees F of set point 3 Adjustable shelves Digital control Stainless steel door Audible and visual over-temp alarm Data Logger Mobile Base Electrical: 120V, 7.5 Amp, 50/60 Hz .49kw/hr, 1678 btu/hr
M.A.C. MEDICAL INC.
FHCSWC2460-TL-D-MB
In Commercial Distribution

  • B286FHCSWC2460TLDMB1 ()
FHCSWC2460-TL-D-MB

  • Blanket warming cabinet, dry-heat

SINGLE CHAMBER WARMING CABINET GLASS DOOR - B286FHCSWC1824TLGDMS1

Overall size 24”W x 20.5”D x 24.5”T. 3.0 Cubic ft. storage Chamber I.D. 20”W x 17"D x 15.25”T Temperature Range: 90-160 F Accuracy +/- 1 degrees F Digital control. Glass door Audible and visual over-temp alarm. Keyed temperature lock for each chamber Data Logger Foot levelers Mobile Stand Electrical: 120V, 3.5 Amp, 50/60 Hz. .45kw/hr, 1537 btu/hr.
M.A.C. MEDICAL INC.
FHCSWC1824-TL-G-D-MS
In Commercial Distribution

  • B286FHCSWC1824TLGDMS1 ()
FHCSWC1824-TL-G-D-MS

  • Blanket warming cabinet, dry-heat

SINGLE CHAMBER WARMING CABINET GLASS DOOR - B286FHCSWC1824TLGDB1

Overall size 24”W x 20.5”D x 24.5”T. 3.0 Cubic ft. storage Chamber I.D. 20”W x 17"D x 15.25”T Temperature Range: 90-160 F Accuracy +/- 1 degrees F Digital control. Glass door Audible and visual over-temp alarm. Keyed temperature lock for each chamber Data Logger Foot levelers 2 Pull-out bins Electrical: 120V, 3.5 Amp, 50/60 Hz. .45kw/hr, 1537 btu/hr.
M.A.C. MEDICAL INC.
FHCSWC1824-TL-G-D-B
In Commercial Distribution

  • B286FHCSWC1824TLGDB1 ()
FHCSWC1824-TL-G-D-B

  • Blanket warming cabinet, dry-heat
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