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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Disposable patient interface with filter 0004-4012
Shape Medical Systems, Inc.
0004-4012
In Commercial Distribution

  • B20044012 ()


  • Pulmonary function testing kit
Disposable Patient Interface is part of the Shape-HF testing system
Shape Medical Systems, Inc.
Disposable Patient Interface
In Commercial Distribution

  • B20044001 ()


  • Pulmonary function testing kit
IMPEDE-FX Embolization Plug 12mm
SHAPE MEMORY MEDICAL INC
IMP-FX-12
Not in Commercial Distribution

  • B054IMPFX121 ()
IMP-FX-12

  • Extraluminal vascular occluder, single-use
IMPEDE-FX Embolization Plug 8mm
SHAPE MEMORY MEDICAL INC
IMP-FX-08
Not in Commercial Distribution

  • B054IMPFX081 ()
IMP-FX-08

  • Extraluminal vascular occluder, single-use
IMPEDE-FX Embolization Plug 6mm
SHAPE MEMORY MEDICAL INC
IMP-FX-06
Not in Commercial Distribution

  • B054IMPFX061 ()
IMP-FX-06

  • Extraluminal vascular occluder, single-use
IMPEDE Embolization Plug 10mm
SHAPE MEMORY MEDICAL INC
IMP-10
Not in Commercial Distribution

  • B054IMP101 ()
IMP-10

  • Extraluminal vascular occluder, single-use
IMPEDE Embolization Plug 7mm
SHAPE MEMORY MEDICAL INC
IMP-07
Not in Commercial Distribution

  • B054IMP071 ()
IMP-07

  • Extraluminal vascular occluder, single-use
IMPEDE Embolization Plug 5mm
SHAPE MEMORY MEDICAL INC
IMP-05
Not in Commercial Distribution

  • B054IMP051 ()
IMP-05

  • Extraluminal vascular occluder, single-use
IMPEDE-FX Embolization Plug, 12mm
SHAPE MEMORY MEDICAL INC
IMP-FX-12
In Commercial Distribution

  • 10810041650051 ()
  • 00810041650054 ()
  • B054IMPFX121 ()
IMP-FX-12

  • Extraluminal vascular occluder, single-use
IMPEDE-FX Embolization Plug, 8mm
SHAPE MEMORY MEDICAL INC
IMP-FX-08
In Commercial Distribution

  • 10810041650044 ()
  • 00810041650047 ()
  • B054IMPFX081 ()
IMP-FX-08

  • Extraluminal vascular occluder, single-use
IMPEDE-FX Embolization Plug, 6mm
SHAPE MEMORY MEDICAL INC
IMP-FX-06
In Commercial Distribution

  • 10810041650037 ()
  • 00810041650030 ()
  • B054IMPFX061 ()
IMP-FX-06

  • Extraluminal vascular occluder, single-use
IMPEDE Embolization Plug, 10mm
SHAPE MEMORY MEDICAL INC
IMP-10
In Commercial Distribution

  • 10810041650020 ()
  • 00810041650023 ()
  • B054IMP101 ()
IMP-10

  • Extraluminal vascular occluder, single-use
IMPEDE Embolization Plug, 7mm
SHAPE MEMORY MEDICAL INC
IMP-07
In Commercial Distribution

  • 10810041650013 ()
  • 00810041650016 ()
  • B054IMP071 ()
IMP-07

  • Extraluminal vascular occluder, single-use
IMPEDE Embolization Plug, 5mm
SHAPE MEMORY MEDICAL INC
IMP-05
In Commercial Distribution

  • 10810041650006 ()
  • 00810041650009 ()
IMP-05

  • Extraluminal vascular occluder, single-use
Essix C+ plastic .040 square blue 25PK
DENTSPLY SIRONA ORTHODONTICS INC.
1C500-BL
In Commercial Distribution

  • D7461C500BL1 ()
  • D7461C500BL0 ()
1C500-BL

  • Dental appliance fabrication material, thermoplastic
Essix C+ Plastic .040 x 5" Square 50pk
DENTSPLY SIRONA ORTHODONTICS INC.
1C500-50
In Commercial Distribution

  • D7461C500501 ()
  • D7461C500500 ()
1C500-50

  • Dental appliance fabrication material, thermoplastic
Essix C+ Plastic .040 x 5" Square 100pk
DENTSPLY SIRONA ORTHODONTICS INC.
1C500
In Commercial Distribution

  • D7461C5001 ()
  • D7461C5000 ()
1C500

  • Dental appliance fabrication material, thermoplastic
ESSIX C+® Plastic - .040in 125mm Sq
DENTSPLY SIRONA ORTHODONTICS INC.
1C478-50
Not in Commercial Distribution

  • D7461C478501 ()
  • D7461C478500 ()
1C478-50

  • Dental appliance fabrication material, thermoplastic
Essix C+ Plastic .040 x 4.92" Square 100PK
DENTSPLY SIRONA ORTHODONTICS INC.
1C478
In Commercial Distribution

  • D7461C4781 ()
  • D7461C4780 ()
1C478

  • Dental appliance fabrication material, thermoplastic
ESSIX C+® Plastic - .040in 135mm Circle
DENTSPLY SIRONA ORTHODONTICS INC.
1C135-50
Not in Commercial Distribution

  • D7461C135501 ()
  • D7461C135500 ()
1C135-50

  • Dental appliance fabrication material, thermoplastic
ESSIX C+® Plastic - .040in 135mm Circle
DENTSPLY SIRONA ORTHODONTICS INC.
1C135
Not in Commercial Distribution

  • D7461C1351 ()
  • D7461C1350 ()
1C135

  • Dental appliance fabrication material, thermoplastic
Essix C+ .040 x 125mm circle yellow 25PK
DENTSPLY SIRONA ORTHODONTICS INC.
1C125-YE
Not in Commercial Distribution

  • D7461C125YE1 ()
  • D7461C125YE0 ()
1C125-YE

  • Dental appliance fabrication material, thermoplastic
ESSIX C+® Plastic - .040in 125mm Ci r- Tooth Color
DENTSPLY SIRONA ORTHODONTICS INC.
1C125-TC
Not in Commercial Distribution

  • D7461C125TC1 ()
  • D7461C125TC0 ()
1C125-TC

  • Dental appliance fabrication material, thermoplastic
Essix C+ Plastic .040 x 125mm Circle 20pk
DENTSPLY SIRONA ORTHODONTICS INC.
1C125-SH
Not in Commercial Distribution

  • D7461C125SH1 ()
  • D7461C125SH0 ()
1C125-SH

  • Dental appliance fabrication material, thermoplastic
Essix C+ Plastic .040 x 125mm circle red 25pk
DENTSPLY SIRONA ORTHODONTICS INC.
1C125-RD
Not in Commercial Distribution

  • D7461C125RD1 ()
  • D7461C125RD0 ()
1C125-RD

  • Dental appliance fabrication material, thermoplastic
ESSIX C+® Plastic - .040in 125mm Circle - Assort. C
DENTSPLY SIRONA ORTHODONTICS INC.
1C125-OC
Not in Commercial Distribution

  • D7461C125OC1 ()
  • D7461C125OC0 ()
1C125-OC

  • Dental appliance fabrication material, thermoplastic
Essix C+ Plastic .040 x 125mm circle green 25pk
DENTSPLY SIRONA ORTHODONTICS INC.
1C125-GR
Not in Commercial Distribution

  • D7461C125GR1 ()
  • D7461C125GR0 ()
1C125-GR

  • Dental appliance fabrication material, thermoplastic
Essix C+ Plastic .040 125mm circle blue 25PK
DENTSPLY SIRONA ORTHODONTICS INC.
1C125-BL
Not in Commercial Distribution

  • D7461C125BL1 ()
  • D7461C125BL0 ()
1C125-BL

  • Dental appliance fabrication material, thermoplastic
Essix C+ Plastic .040 x 125mm Circle 50pk
DENTSPLY SIRONA ORTHODONTICS INC.
1C125-50
In Commercial Distribution

  • D7461C125501 ()
  • D7461C125500 ()
1C125-50

  • Dental appliance fabrication material, thermoplastic
Essix C+ Plastic .040 x 125mm Circle 100pk
DENTSPLY SIRONA ORTHODONTICS INC.
1C125
In Commercial Distribution

  • D7461C1251 ()
  • D7461C1250 ()
1C125

  • Dental appliance fabrication material, thermoplastic
Essix C+ Plastic .040 x 120mm Circle 50pk
DENTSPLY SIRONA ORTHODONTICS INC.
1C120-50
In Commercial Distribution

  • D7461C120501 ()
  • D7461C120500 ()
1C120-50

  • Dental appliance fabrication material, thermoplastic
Essix C+ Plastic .040 x 120mm Circle 100PK
DENTSPLY SIRONA ORTHODONTICS INC.
1C120
In Commercial Distribution

  • D7461C1201 ()
  • D7461C1200 ()
1C120

  • Dental appliance fabrication material, thermoplastic
Essix PLUS Plastic 80 ct .040 (1mm) - 5" Square
DENTSPLY SIRONA ORTHODONTICS INC.
1APL40S5
In Commercial Distribution

  • D7461APL40S51 ()
  • D7461APL40S50 ()
1APL40S5

  • Dental appliance fabrication material, thermoplastic
Essix PLUS Plastic 80 ct .040 (1mm) -125mm Square
DENTSPLY SIRONA ORTHODONTICS INC.
1APL40S125
In Commercial Distribution

  • D7461APL40S1251 ()
  • D7461APL40S1250 ()
1APL40S125

  • Dental appliance fabrication material, thermoplastic
Essix PLUS Plastic 80 ct .040 (1 mm) -125mm circle
DENTSPLY SIRONA ORTHODONTICS INC.
1APL40C125
In Commercial Distribution

  • D7461APL40C1251 ()
  • D7461APL40C1250 ()
1APL40C125

  • Dental appliance fabrication material, thermoplastic
Essix PLUS Plastic 80 ct .040 1 mm) - 120mm circle
DENTSPLY SIRONA ORTHODONTICS INC.
1APL40C120
In Commercial Distribution

  • D7461APL40C1201 ()
  • D7461APL40C1200 ()
1APL40C120

  • Dental appliance fabrication material, thermoplastic
Essix PLUS Plastic 80 ct .035 (7/8mm) - 5" square
DENTSPLY SIRONA ORTHODONTICS INC.
1APL35S5
In Commercial Distribution

  • D7461APL35S51 ()
  • D7461APL35S50 ()
1APL35S5

  • Dental appliance fabrication material, thermoplastic
Essix PLUS Plastic 80 ct .035 (7/8mm) - 125mm square
DENTSPLY SIRONA ORTHODONTICS INC.
1APL35S125
In Commercial Distribution

  • D7461APL35S1251 ()
  • D7461APL35S1250 ()
1APL35S125

  • Dental appliance fabrication material, thermoplastic
Essix PLUS Plastic 80 ct .035 (7/8mm) - 125mm circle
DENTSPLY SIRONA ORTHODONTICS INC.
1APL35C125
In Commercial Distribution

  • D7461APL35C1251 ()
  • D7461APL35C1250 ()
1APL35C125

  • Dental appliance fabrication material, thermoplastic
Essix PLUS Plastic 80 ct .035 (7/8mm) - 120mm circle
DENTSPLY SIRONA ORTHODONTICS INC.
1APL35C120
In Commercial Distribution

  • D7461APL35C1201 ()
  • D7461APL35C1200 ()
1APL35C120

  • Dental appliance fabrication material, thermoplastic
Essix ACE® Plastic - .035in Vac 5" Square
DENTSPLY SIRONA ORTHODONTICS INC.
1AH50PLAS
Not in Commercial Distribution

  • D7461AH50PLAS1 ()
  • D7461AH50PLAS0 ()
1AH50PLAS

  • Dental appliance fabrication material, thermoplastic
Essix ACE Plastic .035 x 125mm Square 50pk
DENTSPLY SIRONA ORTHODONTICS INC.
1AH50-50
Not in Commercial Distribution

  • D7461AH50501 ()
  • D7461AH50500 ()
1AH50-50

  • Dental appliance fabrication material, thermoplastic
Essix ACE Plastic .035 x Vacuum Square 100pk
DENTSPLY SIRONA ORTHODONTICS INC.
1AH50
In Commercial Distribution

  • D7461AH501 ()
  • D7461AH500 ()
1AH50

  • Dental appliance fabrication material, thermoplastic
Essix ACE® Plastic - .035in 125mm Square
DENTSPLY SIRONA ORTHODONTICS INC.
1AH347-50
Not in Commercial Distribution

  • D7461AH347501 ()
  • D7461AH347500 ()
1AH347-50

  • Dental appliance fabrication material, thermoplastic
Essix ACE Plastic - .035in 125mm Square 100pk
DENTSPLY SIRONA ORTHODONTICS INC.
1AH347
In Commercial Distribution

  • D7461AH3471 ()
  • D7461AH3470 ()
1AH347

  • Dental appliance fabrication material, thermoplastic
Essix ACE® Plastic - .035in 125mm Circle Shinwon
DENTSPLY SIRONA ORTHODONTICS INC.
1AH25-SH
Not in Commercial Distribution

  • D7461AH25SH1 ()
  • D7461AH25SH0 ()
1AH25-SH

  • Dental appliance fabrication material, thermoplastic
Essix ACE® Plastic - .035in 125mm Circle
DENTSPLY SIRONA ORTHODONTICS INC.
1AH25-50
Not in Commercial Distribution

  • D7461AH25501 ()
  • D7461AH25500 ()
1AH25-50

  • Dental appliance fabrication material, thermoplastic
Essix ACE Plastic 035 x 125mm Circle 100pk
DENTSPLY SIRONA ORTHODONTICS INC.
1AH25
In Commercial Distribution

  • D7461AH251 ()
  • D7461AH250 ()
1AH25

  • Dental appliance fabrication material, thermoplastic
Essix ACE® Plastic - .035in 120mm Circle
DENTSPLY SIRONA ORTHODONTICS INC.
1AH20-50
Not in Commercial Distribution

  • D7461AH20501 ()
  • D7461AH20500 ()
1AH20-50

  • Dental appliance fabrication material, thermoplastic
Essix ACE .035" 120mm Circle 100/PK
DENTSPLY SIRONA ORTHODONTICS INC.
1AH20
In Commercial Distribution

  • D7461AH201 ()
  • D7461AH200 ()
1AH20

  • Dental appliance fabrication material, thermoplastic
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