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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GammaPro Angled Standard Probe used for wireless ionizing radiation detection.
Kubtec
K0021C01
In Commercial Distribution

  • B619GPROSTDANGPROBE0 ()


  • Mobile gamma camera system
GammaPro Laparoscopic Probe used for wireless ionizing radiation detection.
Kubtec
K0020C01
In Commercial Distribution

  • B619GPROLAPPROBE0 ()


  • Mobile gamma camera system
GammaPro Laparoscopic Probe with Tablet and Carry Case used for wireless ionizing radiation detection.
Kubtec
K0020C02
In Commercial Distribution

  • B619GPROLAPKIT0 ()


  • Mobile gamma camera system
GammaPro High Sensitivity Probe used for wireless ionizing radiation detection.
Kubtec
K0019C01
In Commercial Distribution

  • B619GPROHISPROBE0 ()


  • Mobile gamma camera system
GammaPro Hi-Sense Probe with Tablet and Carry Case used for wireless ionizing radiation detection.
Kubtec
K0019C02
In Commercial Distribution

  • B619GPROHISKIT0 ()


  • Mobile gamma camera system
Table with installed software is used with wireless battery powered probes (different shapes and sizes) to detect a determined range of gamma radiation energies and maximizes sensitivity and directivity.
Kubtec
K0017C01
In Commercial Distribution

  • B619GPROCASETABL2 ()


  • Mobile gamma camera system
Stat Profile pHOx Ultra/CCX Control CO-Ox Tri Level L7, 8 ,9 (amps)
NOVA BIOMEDICAL CORPORATION
phox ultra/ccx
In Commercial Distribution

  • 00385480491877 ()
  • 00385489491878 ()
49187

  • Assisted reproduction centrifuge tube
Stat Profile pHOx Ultra/CCX Control Chemistry L4, 5 (amps)
NOVA BIOMEDICAL CORPORATION
phox ultra/ccx
In Commercial Distribution

  • 00385480491846 ()
  • 00385489491847 ()
49184

  • Assisted reproduction centrifuge tube
Stat Profile pHOx Ultra/CCX Blood Gas Controls Multipack L1, 2, 3 (Amps)
NOVA BIOMEDICAL CORPORATION
phox ultra/ccx
In Commercial Distribution

  • 00385480489355 ()
  • 00385489489356 ()
48935

  • Assisted reproduction centrifuge tube
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
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 B4
In Commercial Distribution

  • D960BPMB4141 ()
30112208

  • 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 B3
In Commercial Distribution

  • D960BPMB3141 ()
30112207

  • 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 B2
In Commercial Distribution

  • D960BPMB2141 ()
30112206

  • 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 B1
In Commercial Distribution

  • D960BPMB1141 ()
30112205

  • 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 A3.5
In Commercial Distribution

  • D960BPMA5141 ()
30112203

  • 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 A4
In Commercial Distribution

  • D960BPMA4141 ()
30112204

  • 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 A3
In Commercial Distribution

  • D960BPMA3141 ()
30112202

  • 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 A2
In Commercial Distribution

  • D960BPMA2141 ()
30112201

  • 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 A1
In Commercial Distribution

  • D960BPMA1141 ()
30112200

  • Dental appliance fabrication material, ceramic
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11668590
In Commercial Distribution

  • 04056869996295 ()


  • General-purpose ultrasound imaging system
Xpert Flu kit; 10 test kit
CEPHEID
GXFLU-10A
Not in Commercial Distribution

  • 07332940001070 ()
GXFLU-10A

  • Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Smoke Shark III Smoke Evacuator 100V-120V 50/60Hz
Conmed Corporation
SE03-120
In Commercial Distribution

  • 20845854600099 ()
  • 10845854600092 ()
SE03-120

  • Surgical plume evacuation system
Smoke Shark III Smoke Evacuator 220V-240V 50/60Hz
Conmed Corporation
SE03-220
In Commercial Distribution

  • 20845854600082 ()
  • 10845854600085 ()
SE03-220

  • Surgical plume evacuation system
MiniVac Smoke Evacuation System 220-240V 50/60 Hz
Conmed Corporation
ECVV220
Not in Commercial Distribution

ECVV220

  • Surgical plume evacuation system
MiniVac Smoke Evacuation System 100V-120V 50/60 Hz
Conmed Corporation
ECVV120
In Commercial Distribution

  • 10614559104422 ()
  • 10845854053096 ()
  • 30845854053090 ()
ECVV120

  • 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
ICM-000-0643 STERIS RF Sensor, Shielded
I.C. MEDICAL, INC.
SSESEN01
In Commercial Distribution

  • 00817688023500 ()
SSESEN01

  • Surgical plume evacuation system
ICM-000-0606 STERIS Large Coconut Charcoal Output Filter, Non-Sterile
I.C. MEDICAL, INC.
SSEFIL02
In Commercial Distribution

  • 00817688023012 ()
SSEFIL02

  • Surgical plume evacuation system
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