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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AccuSign® AMP card; 35 Test kit; CE
PRINCETON BIOMEDITECH CORPORATION
DOA-204-35-02
In Commercial Distribution

  • 10743816000105 ()
DOA-204-35-02

  • Amphetamine-specific IVD, kit, rapid ICT, clinical
AccuSign® OPI card; 35 Test kit; CE
PRINCETON BIOMEDITECH CORPORATION
DOA-203-35-02
In Commercial Distribution

  • 10743816000082 ()
DOA-203-35-02

  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
AccuSign® MET 500 card; 35 Test kit
PRINCETON BIOMEDITECH CORPORATION
DOA-202E-35-00
In Commercial Distribution

  • 10743816000075 ()
DOA-202E-35-00

  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
AccuSign® MET card; 35 Test kit; CE
PRINCETON BIOMEDITECH CORPORATION
DOA-202-35-02
In Commercial Distribution

  • 10743816000051 ()
DOA-202-35-02

  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
AccuSign® THC card; 35 Test kit; CE
PRINCETON BIOMEDITECH CORPORATION
DOA-201-35-02
In Commercial Distribution

  • 10743816000037 ()
DOA-201-35-02

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
AccuSign® COC card; 35 Test kit; CE
PRINCETON BIOMEDITECH CORPORATION
DOA-200-35-02
In Commercial Distribution

  • 10743816000013 ()
DOA-200-35-02

  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
BRACKETS 35 VS MIDI DIAG 22 T-22 BH
LEONE SPA
F4210-935
In Commercial Distribution

  • 08033707085638 ()
F4210-935

  • Orthodontic bracket, metal
BRACKETS 35 VS MIDI DIAG 18 T-22 BH
LEONE SPA
F4270-35
In Commercial Distribution

  • 08033707084358 ()
F4270-35

  • Orthodontic bracket, metal
BKT 35 F1000 SELF-LIGATING 22 T-17A+2 BH
LEONE SPA
F1000-35
In Commercial Distribution

  • 08033707080497 ()
F1000-35

  • Self-ligating orthodontic bracket
DB BRACKETS 35 MINI DIAG 18 T-22 BH
LEONE SPA
F7175C907
In Commercial Distribution

  • 08033707091608 ()
F7175C907

  • Orthodontic bracket, metal
DB BRACKETS 35 MINI DIAG 22 T-22 BH
LEONE SPA
F7115C907
In Commercial Distribution

  • 08033707091486 ()
F7115C907

  • Orthodontic bracket, metal
DB BRACKETS 35 MINI DIAG 18 T-15 BH
LEONE SPA
F7075C907
In Commercial Distribution

  • 08033707091240 ()
F7075C907

  • Orthodontic bracket, metal
BRACKETS 35 VS MIDI DIAG 18 T-22 BH
LEONE SPA
F4270-935
In Commercial Distribution

  • 08033707085836 ()
F4270-935

  • Orthodontic bracket, metal
BRACKETS 35 LOGIC STEP 22 VS20 T-17A+2BH
LEONE SPA
F6113-35
In Commercial Distribution

  • 08033707084587 ()
F6113-35

  • Orthodontic bracket, metal
BRACKETS 35 VS MIDI DIAG 22 T-22 BH
LEONE SPA
F4210-35
In Commercial Distribution

  • 08033707083979 ()
F4210-35

  • Orthodontic bracket, metal
Prosthetic Driver for JDTorque L 35 JDEvolution Plus
J DENTAL CARE SRL
Prosthetic Driver for JDTorque L 35 JDEvolution Plus
In Commercial Distribution

  • 08056591010807 ()
EVSDPF35:

  • Dental implant system
Diameter 8.5 mm x 35 mm Monoaxial Screw
Ortho Development Corporation
752-8535-31
Not in Commercial Distribution

  • 00822409029594 ()

  • Outer Diameter: 8.5 Millimeter
  • Length: 35 Millimeter


  • Spinal bone screw, non-bioabsorbable
Diameter 7.5 mm x 35 mm Monoaxial Screw
Ortho Development Corporation
752-7535-31
Not in Commercial Distribution

  • 00822409029143 ()

  • Length: 35 Millimeter
  • Outer Diameter: 7.5 Millimeter


  • Spinal bone screw, non-bioabsorbable
Diameter 7.5 mm x 35 mm Polyaxial Screw
Ortho Development Corporation
752-7535-11
Not in Commercial Distribution

  • 00822409029105 ()

  • Length: 35 Millimeter
  • Outer Diameter: 7.5 Millimeter


  • Spinal bone screw, non-bioabsorbable
Diameter 8.5 mm x 35 mm Polyaxial Screw
Ortho Development Corporation
752-8535-11
Not in Commercial Distribution

  • 00822409029556 ()

  • Length: 35 Millimeter
  • Outer Diameter: 8.5 Millimeter


  • Spinal bone screw, non-bioabsorbable
Diameter 6.5 mm x 35 mm Monoaxial Screw
Ortho Development Corporation
752-6535-31
Not in Commercial Distribution

  • 00822409028696 ()

  • Outer Diameter: 6.5 Millimeter
  • Length: 35 Millimeter


  • Spinal bone screw, non-bioabsorbable
Diameter 6.5 mm x 35 mm Polyaxial Screw
Ortho Development Corporation
752-6535-11
Not in Commercial Distribution

  • 00822409028658 ()

  • Length: 35 Millimeter
  • Outer Diameter: 6.5 Millimeter


  • Spinal bone screw, non-bioabsorbable
Diameter 5.5 mm x 35 mm Monoaxial Screw
Ortho Development Corporation
752-5535-31
Not in Commercial Distribution

  • 00822409028337 ()

  • Length: 35 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Spinal bone screw, non-bioabsorbable
Diameter 5.5 mm x 35 mm Polyaxial Screw
Ortho Development Corporation
752-5535-11
Not in Commercial Distribution

  • 00822409028290 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 35 Millimeter


  • Spinal bone screw, non-bioabsorbable
Diameter 4.5 mm x 35 mm Monoaxial Screw
Ortho Development Corporation
752-4535-31
Not in Commercial Distribution

  • 00822409027972 ()

  • Length: 35 Millimeter
  • Outer Diameter: 4.5 Millimeter


  • Spinal bone screw, non-bioabsorbable
Diameter 4.5 mm x 35 mm Polyaxial Screw
Ortho Development Corporation
752-4535-11
Not in Commercial Distribution

  • 00822409027934 ()

  • Length: 35 Millimeter
  • Outer Diameter: 4.5 Millimeter


  • Spinal bone screw, non-bioabsorbable
CALIBRA 1ST MOL BANDS W/G8325-02 n.UR 35
LEONE SPA
E1520-35
In Commercial Distribution

  • 08033707014157 ()
E1520-35

  • Orthodontic metal band
CALIBRA 1ST MOL BANDS W/G8025-02 n.LL 35
LEONE SPA
E1475-35
In Commercial Distribution

  • 08033707013792 ()
E1475-35

  • Orthodontic metal band
CALIBRA 1ST MOL BANDS W/G8025-02 n.LL 35
LEONE SPA
E1470-35
In Commercial Distribution

  • 08033707013419 ()
E1470-35

  • Orthodontic metal band
CALIBRA 1ST MOL BANDS W/G8025-03 n.LR 35
LEONE SPA
E1465-35
In Commercial Distribution

  • 08033707013051 ()
E1465-35

  • Orthodontic metal band
CALIBRA 1ST MOL BANDS W/G8025-03 n.LR 35
LEONE SPA
E1460-35
In Commercial Distribution

  • 08033707012672 ()
E1460-35

  • Orthodontic metal band
CALIBRA 1ST MOL BANDS W/G8025-03 n.UL 35
LEONE SPA
E1435-35
In Commercial Distribution

  • 08033707012313 ()
E1435-35

  • Orthodontic metal band
CALIBRA 1ST MOL BANDS W/G8025-03 n.UL 35
LEONE SPA
E1430-35
In Commercial Distribution

  • 08033707011934 ()
E1430-35

  • Orthodontic metal band
CALIBRA 1ST MOL BANDS W/G8025-02 n.UR 35
LEONE SPA
E1425-35
In Commercial Distribution

  • 08033707011576 ()
E1425-35

  • Orthodontic metal band
CALIBRATE 1ST MOLAR BANDS WL n. UR 35
LEONE SPA
E1203-935
In Commercial Distribution

  • 08033707009368 ()
E1203-935

  • Orthodontic metal band
CALIBRA 1ST MOL BANDS W/G8025-02 n.UR 35
LEONE SPA
E1420-35
In Commercial Distribution

  • 08033707011194 ()
E1420-35

  • Orthodontic metal band
CALIBRATE 1ST MOLAR BANDS WL n. UL 35
LEONE SPA
E1303-935
In Commercial Distribution

  • 08033707010470 ()
E1303-935

  • Orthodontic metal band
CALIBRA 1ST MOL BANDS W/G8325-03 n.UL 35
LEONE SPA
E1535-35
In Commercial Distribution

  • 08033707015277 ()
E1535-35

  • Orthodontic metal band
CALIBRA 1ST MOL BANDS W/G8325-02 n.UR 35
LEONE SPA
E1525-35
In Commercial Distribution

  • 08033707014539 ()
E1525-35

  • Orthodontic metal band
CALIBRATE 1ST MOLAR BANDS WL n. LL 35
LEONE SPA
E1703-935
In Commercial Distribution

  • 08033707018612 ()
E1703-935

  • Orthodontic metal band
CALIBRATE 1ST MOLAR BANDS WL n. LR 35
LEONE SPA
E1603-935
In Commercial Distribution

  • 08033707017509 ()
E1603-935

  • Orthodontic metal band
CALIBRA 1ST MOL BANDS W/G8325-07 n.LL 35
LEONE SPA
E1575-35
In Commercial Distribution

  • 08033707016755 ()
E1575-35

  • Orthodontic metal band
CALIBRA 1ST MOL BANDS W/G8325-07 n.LL 35
LEONE SPA
E1570-35
In Commercial Distribution

  • 08033707016373 ()
E1570-35

  • Orthodontic metal band
CALIBRA 1ST MOL BANDS W/G8325-06 n.LR 35
LEONE SPA
E1565-35
In Commercial Distribution

  • 08033707016014 ()
E1565-35

  • Orthodontic metal band
CALIBRA 1ST MOL BANDS W/G8325-06 n.LR 35
LEONE SPA
E1560-35
In Commercial Distribution

  • 08033707015635 ()
E1560-35

  • Orthodontic metal band
CALIBRA 1ST MOL BANDS W/G8325-03 n.UL 35
LEONE SPA
E1530-35
In Commercial Distribution

  • 08033707014898 ()
E1530-35

  • Orthodontic metal band
DB BRACKETS 35 MINI DIAG 22 T-22 BH
LEONE SPA
F7115-907
In Commercial Distribution

  • 08033707054566 ()
F7115-907

  • Orthodontic bracket, metal
DB BRACKETS 35 MINI DIAG 22 T-22 BH
LEONE SPA
F7115-07
In Commercial Distribution

  • 08033707054542 ()
F7115-07

  • Orthodontic bracket, metal
DB BRACKETS 35 MINI DIAG 18 T-15 BH
LEONE SPA
F7075-907
In Commercial Distribution

  • 08033707053941 ()
F7075-907

  • Orthodontic bracket, metal
DB BRACKETS 35 LOGIC ROTH 22 T-22 BH
LEONE SPA
F6212-935
In Commercial Distribution

  • 08033707053224 ()
F6212-935

  • Orthodontic bracket, metal
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