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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Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / M-AMP / MTD / OPI / OXY
RAPID DIAGNOSTICS INC
07RD-7065-39
In Commercial Distribution

  • 00817830022726 ()

  • Length: 75 Millimeter
07RD-7065-39

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / COC / MET / OPI / OXY / THC
RAPID DIAGNOSTICS INC
07RD-7070-11
In Commercial Distribution

  • 00817830022696 ()

  • Length: 75 Millimeter
07RD-7070-11

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
No Description
MAZOR ROBOTICS LTD
MAS1891-04
Not in Commercial Distribution

  • 07290109182063 ()
MAS1891-04S

  • Stereotactic surgery system probe, reusable
No Description
MAZOR ROBOTICS LTD
MAS1891-06S
In Commercial Distribution

  • 07290115751581 ()


  • Stereotactic surgery system probe, reusable
AQUIOS Tetra-2+ Panel CD45-FITC/(CD56 + CD16)-RD1/CD19-ECD/CD3-PC5
BECKMAN COULTER IRELAND INC.
B23534
In Commercial Distribution

  • 15099590225735 ()
B23534

  • Multiple CD cell marker IVD, antibody
AQUIOS Tetra-1 Panel CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5
BECKMAN COULTER IRELAND INC.
B23533
In Commercial Distribution

  • 15099590225704 ()
B23533

  • Multiple CD cell marker IVD, antibody
No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804801823 ()


  • Amphetamine-specific IVD, kit, rapid ICT, clinical
No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804801816 ()


  • Benzodiazepine group IVD, kit, rapid ICT, clinical
No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804801809 ()


  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804801793 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804801786 ()


  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804801779 ()


  • Amphetamine-specific IVD, kit, rapid ICT, clinical
No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804801762 ()


  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804801755 ()


  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804801748 ()


  • Amphetamine-specific IVD, kit, rapid ICT, clinical
No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804801731 ()


  • Methadone IVD, kit, rapid ICT, clinical
No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804801724 ()


  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804801717 ()


  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804801700 ()


  • Barbiturate IVD, kit, rapid ICT, clinical
Under cabinet side mount 12 o'clock rear delivery (assistant's instruments only)
Engle Dental Systems, LLC
P071470
In Commercial Distribution

  • 00850043433507 ()
P071470

  • Dental delivery system instrument unit, pneumatic
Chair mounted left / right convertible delivery system with E2 control head
Engle Dental Systems, LLC
P070941
In Commercial Distribution

  • 00850043433484 ()
P070941

  • Dental delivery system instrument unit, pneumatic
Chair mounted utility center with cuspidor
Engle Dental Systems, LLC
P069240
In Commercial Distribution

  • 00850043433477 ()
P069240

  • Dental delivery system instrument unit, pneumatic
Chair mounted utility center with telescopic arm
Engle Dental Systems, LLC
P069201
In Commercial Distribution

  • 00850043433460 ()
P069201

  • Dental delivery system instrument unit, pneumatic
Chair mounted left / right convertible cuspidor with assistant's group
Engle Dental Systems, LLC
P069265
In Commercial Distribution

  • 00850043433453 ()
P069265

  • Dental delivery system instrument unit, pneumatic
Central vacuum kit, fixed position
Engle Dental Systems, LLC
P022501
In Commercial Distribution

  • 00850043433446 ()
P022501

  • Dental delivery system instrument unit, pneumatic
Cabinet vacuum group - long arm
Engle Dental Systems, LLC
22-507-02
In Commercial Distribution

  • 00850043433439 ()
22-507-02

  • Dental delivery system instrument unit, pneumatic
Cabinet vacuum group - short arm
Engle Dental Systems, LLC
22-507-01
In Commercial Distribution

  • 00850043433422 ()
22-507-01

  • Dental delivery system instrument unit, pneumatic
Cabinet vacuum group - top mount
Engle Dental Systems, LLC
22-502-02
In Commercial Distribution

  • 00850043433415 ()
22-502-02

  • Dental delivery system instrument unit, pneumatic
Chair mounted left / right convertible assistant's group
Engle Dental Systems, LLC
P022275
In Commercial Distribution

  • 00850043433408 ()
P022275

  • Dental delivery system instrument unit, pneumatic
AS-1 Dr's wall mount delivery system
Engle Dental Systems, LLC
P070876S
In Commercial Distribution

  • 00850043433385 ()
P070876S

  • Dental delivery system instrument unit, pneumatic
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