Company Name Brand Name GMDN Term FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Class Implantable

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Includes TX Nozzle, preliminary filter, 18" hose section assembly, connects to Hose, Intended for long procedures of up to 1 hour duration
ACUDERM, INC.
LTXPACK
In Commercial Distribution

  • 10814105020507 ()


  • Surgical plume evacuation system
Includes TX Nozzle, preliminary filter, 8" hose section assembly, connects to Hose, Intended for short procedures of up to 15 minutes duration
ACUDERM, INC.
TXPACK
In Commercial Distribution

  • 10814105020491 ()


  • Surgical plume evacuation system
Top of the line surgical smoke evacuator. Specifically designed for use with erbium smoke. Also suitable for use with CO2, hair removal, and other laser or electrosurgical units in open procedures or with reducer for handpiece or 220vac motor
ACUDERM, INC.
EVAC II-2
In Commercial Distribution

  • 10814105020460 ()


  • Surgical plume evacuation system
Top of the line surgical smoke evacuator. Specifically designed for use with erbium smoke. Also suitable for use with CO2, hair removal, and other laser or electrosurgical units in open procedures or with reducer for handpiece or laparoscopic use. 110vac motor
ACUDERM, INC.
EVAC II-1
In Commercial Distribution

  • 10814105020453 ()


  • Surgical plume evacuation system
All purpose surgical smoke evacuator. Suitable for use with CO2, erbium, hair removal, and other laser or electrosurgical units in open procedures. 220vac motor
ACUDERM, INC.
EVAC IE-2
In Commercial Distribution

  • 10814105020446 ()


  • Surgical plume evacuation system
All purpose surgical smoke evacuator. Suitable for use with CO2, erbium, hair removal, and other laser or electrosurgical units in open procedures. 110vac motor
ACUDERM, INC.
EVAC IE-1
In Commercial Distribution

  • 10814105020439 ()


  • Surgical plume evacuation system
Wall Mount starter package includes Acu-Evac II, Wall mount bracket, M-1 main filter, Hose and 5 TX Nozzles
ACUDERM, INC.
STARTER-IIW
In Commercial Distribution

  • 10814105020422 ()


  • Surgical plume evacuation system
Wall Mount starter package includes Acu-Evac IE, Wall mount bracket, M-1 main filter, Hose and 5 TX Nozzles
ACUDERM, INC.
STARTER-IEW
In Commercial Distribution

  • 10814105020415 ()


  • Surgical plume evacuation system
Cart mount starter package includes Acu-Evac II unit, Cart, Boom Arm, Foot Switch, M-1 Main Filter, Hose and 5 TX Nozzles.
ACUDERM, INC.
STARTER-II
In Commercial Distribution

  • 10814105020408 ()


  • Surgical plume evacuation system
Cart mount starter package includes Acu-Evac IE unit, Cart, Boom Arm, Foot Switch, M-1 Main Filter, Hose and 5 TX Nozzles.
ACUDERM, INC.
STARTER-IE
In Commercial Distribution

  • 10814105020392 ()


  • Surgical plume evacuation system
TX NOZZLE STARTER KIT PACK, EVAC HOSE 9"" 5/PER BAG
ACUDERM, INC.
TXPACK-1
In Commercial Distribution

  • 00814105021668 ()


  • Surgical plume evacuation system
Rubber feet Acu-Evac 1E or Acu-Evac II when mounting on a tabletop or countertop
ACUDERM, INC.
CTFEET
In Commercial Distribution

  • 00814105020586 ()


  • Surgical plume evacuation system
Cart bracket for mounting of a Hyfrecator or other electrosurgical unit to an Evac cart, above the smoke evacuator
ACUDERM, INC.
CMB
In Commercial Distribution

  • 00814105020579 ()


  • Surgical plume evacuation system
Cart for mounting of Evac unit that provides portability and convenience. Unit has four wheels two of which swivel
ACUDERM, INC.
DUALCART
In Commercial Distribution

  • 00814105020562 ()


  • Surgical plume evacuation system
Wall mount bracket for mounting Acu-Evac IE-1 and Acu-Evac II to a wall
ACUDERM, INC.
EWMB
In Commercial Distribution

  • 00814105020555 ()


  • Surgical plume evacuation system
Pneumatic foot switch provides convenient ON-OFF control of Acu-Evac
ACUDERM, INC.
PFTSW
In Commercial Distribution

  • 00814105020548 ()


  • Surgical plume evacuation system
Flexible boom arm holds hose and nozzle in place for hands free operation. Not intended for use with lasers.
ACUDERM, INC.
ARM
In Commercial Distribution

  • 00814105020531 ()


  • Surgical plume evacuation system
Hose connector used to connect TX Pack or LTX Pack to hose
ACUDERM, INC.
HOSECON
In Commercial Distribution

  • 00814105020524 ()


  • Surgical plume evacuation system
6 ft. long x 1.3" diameter hose with connector for use with TX Pack or LTX Pack
ACUDERM, INC.
HOSE
In Commercial Distribution

  • 00814105020517 ()


  • Surgical plume evacuation system
Consists of a charcoal/odor filter and an ULPA filter-rated 99.9997% efficiency on particles 0..01 micron and 0.12 microns MPPS. Normal use filter life: 32 hours except for erbium smoke.
ACUDERM, INC.
M2-FILTER
In Commercial Distribution

  • 00814105020487 ()


  • Surgical plume evacuation system
Consists of a charcoal/odor filter and an ULPA filter-rated 99.9997% efficiency on particles 0..01 micron and 0.12 microns MPPS. Normal use filter life: 16 hours except for erbium smoke.
ACUDERM, INC.
M1-FILTER
In Commercial Distribution

  • 00814105020470 ()


  • Surgical plume evacuation system
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega EMG- recording with Full Stimulation Source
In Commercial Distribution

  • 27290016450938 ()
750-02J013-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega ECoG- Recording with Full Stimulation Source
In Commercial Distribution

  • 27290016450891 ()
750-02J016-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega ECoG Recording Kit
In Commercial Distribution

  • 27290016450877 ()
750-02A016-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega EEG Recording Kit
In Commercial Distribution

  • 27290016450853 ()
750-02A011-00

  • Depth electrode
Origin Live are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Live can be used for all dental constructions incl. bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
Live 30mm
In Commercial Distribution

  • D960LVX00301 ()
30101109

  • Dental appliance fabrication material, ceramic
Origin Live are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Live can be used for all dental constructions incl. bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
Live 28mm
In Commercial Distribution

  • D960LVX00281 ()
30101108

  • Dental appliance fabrication material, ceramic
Origin Live are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Live can be used for all dental constructions incl. bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
Live 25mm
In Commercial Distribution

  • D960LVX00251 ()
30101107

  • Dental appliance fabrication material, ceramic
Origin Live are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Live can be used for all dental constructions incl. bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
Live 24mm
In Commercial Distribution

  • D960LVX00241 ()
30101110

  • Dental appliance fabrication material, ceramic
Origin Live are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Live can be used for all dental constructions incl. bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
Live 22mm
In Commercial Distribution

  • D960LVX00221 ()
30101106

  • Dental appliance fabrication material, ceramic
Origin Live are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Live can be used for all dental constructions incl. bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
Live 20mm
In Commercial Distribution

  • D960LVX00201 ()
30101105

  • Dental appliance fabrication material, ceramic
Origin Live are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Live can be used for all dental constructions incl. bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
Live 18mm
In Commercial Distribution

  • D960LVX00181 ()
30101104

  • Dental appliance fabrication material, ceramic
Origin Live are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Live can be used for all dental constructions incl. bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
Live 16mm
In Commercial Distribution

  • D960LVX00161 ()
30101103

  • Dental appliance fabrication material, ceramic
Origin Live are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Live can be used for all dental constructions incl. bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
Live 14mm
In Commercial Distribution

  • D960LVX00141 ()
30101102

  • Dental appliance fabrication material, ceramic
Origin Live are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Live can be used for all dental constructions incl. bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
Live 12mm
In Commercial Distribution

  • D960LVX00121 ()
30101101

  • Dental appliance fabrication material, ceramic
Origin Live are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Live can be used for all dental constructions incl. bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
Live 10mm
In Commercial Distribution

  • D960LVX00101 ()
30101100

  • Dental appliance fabrication material, ceramic
Origin Beyond Plus white are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus white mono can be used for all dental constructions include bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
98D30mm
In Commercial Distribution

  • D960BPX00301 ()
30111610

  • Dental appliance fabrication material, ceramic
Origin Beyond Plus white are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus white mono can be used for all dental constructions include bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
98D28mm
In Commercial Distribution

  • D960BPX00281 ()
30111609

  • Dental appliance fabrication material, ceramic
Origin Beyond Plus white are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus white mono can be used for all dental constructions include bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
98D25mm
In Commercial Distribution

  • D960BPX00251 ()
30111608

  • Dental appliance fabrication material, ceramic
Origin Beyond Plus white are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus white mono can be used for all dental constructions include bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
98D24mm
In Commercial Distribution

  • D960BPX00241 ()
30111607

  • Dental appliance fabrication material, ceramic
Origin Beyond Plus white are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus white mono can be used for all dental constructions include bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
98D22mm
In Commercial Distribution

  • D960BPX00221 ()
30111606

  • Dental appliance fabrication material, ceramic
Origin Beyond Plus white are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus white mono can be used for all dental constructions include bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
98D20mm
In Commercial Distribution

  • D960BPX00201 ()
30111605

  • Dental appliance fabrication material, ceramic
Origin Beyond Plus white are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus white mono can be used for all dental constructions include bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
98D18mm
In Commercial Distribution

  • D960BPX00181 ()
30111604

  • Dental appliance fabrication material, ceramic
Origin Beyond Plus white are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus white mono can be used for all dental constructions include bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
98D16mm
In Commercial Distribution

  • D960BPX00161 ()
30111603

  • Dental appliance fabrication material, ceramic
Origin Beyond Plus white are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus white mono can be used for all dental constructions include bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
98D14mm
In Commercial Distribution

  • D960BPX00141 ()
30111602

  • Dental appliance fabrication material, ceramic
Origin Beyond Plus white are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus white mono can be used for all dental constructions include bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
98D12mm
In Commercial Distribution

  • D960BPX00121 ()
30111601

  • Dental appliance fabrication material, ceramic
Origin Beyond Plus white are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus white mono can be used for all dental constructions include bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
98D10mm
In Commercial Distribution

  • D960BPX00101 ()
30111600

  • Dental appliance fabrication material, ceramic
Origin Beyond Plus Pre-shaded multi are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus Pre-shaded multi can be used for all dental constructions include bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
98D14mm OM2
In Commercial Distribution

  • D960BPMM2141 ()
30112199

  • Dental appliance fabrication material, ceramic
Origin Beyond Plus Pre-shaded multi are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus Pre-shaded multi can be used for all dental constructions include bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
98D14mm C2
In Commercial Distribution

  • D960BPMC2141 ()
30112210

  • Dental appliance fabrication material, ceramic
Origin Beyond Plus Pre-shaded multi are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus Pre-shaded multi can be used for all dental constructions include bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
98D14mm C1
In Commercial Distribution

  • D960BPMC1141 ()
30112209

  • Dental appliance fabrication material, ceramic
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