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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NextDent C&B MFH / N1
Vertex-Dental B.V.
NOWHHCMN101000
In Commercial Distribution

  • 08719425508320 ()


  • Dental bridge, polymer
  • Dental veneer, professional
  • Temporary dental crown/bridge resin
  • Custom-made dental crown, polymer
  • Dental prosthesis veneer resin
  • Temporary dental crown/bridge
NextDent C&B MFH / N1
Vertex-Dental B.V.
NOHKCMN101000
Not in Commercial Distribution

  • 08719425508313 ()


  • Dental veneer, professional
  • Temporary dental crown/bridge
  • Temporary dental crown/bridge resin
  • Dental bridge, polymer
  • Custom-made dental crown, polymer
  • Dental prosthesis veneer resin
NextDent C&B MFH / BL
Vertex-Dental B.V.
NOWHHCMBL01000
In Commercial Distribution

  • 08719425508306 ()


  • Dental bridge, polymer
  • Temporary dental crown/bridge resin
  • Temporary dental crown/bridge
  • Dental veneer, professional
  • Custom-made dental crown, polymer
  • Dental prosthesis veneer resin
NextDent C&B MFH / BL
Vertex-Dental B.V.
NOHKCMBL01000
Not in Commercial Distribution

  • 08719425508290 ()


  • Temporary dental crown/bridge
  • Custom-made dental crown, polymer
  • Temporary dental crown/bridge resin
  • Dental veneer, professional
  • Dental prosthesis veneer resin
  • Dental bridge, polymer
NextDent C&B MFH / BL
Vertex-Dental B.V.
NDCMBL01000
In Commercial Distribution

  • 08719425508283 ()


  • Dental veneer, professional
  • Custom-made dental crown, polymer
  • Dental prosthesis veneer resin
  • Dental bridge, polymer
  • Temporary dental crown/bridge resin
  • Temporary dental crown/bridge
NextDent C&B MFH / N2
Vertex-Dental B.V.
NDCMN201000
In Commercial Distribution

  • 08719425503295 ()


  • Dental prosthesis veneer resin
  • Dental bridge, polymer
  • Custom-made dental crown, polymer
  • Temporary dental crown/bridge resin
  • Dental veneer, professional
  • Temporary dental crown/bridge
NextDent C&B MFH / N1.5
Vertex-Dental B.V.
NDCMN1.501000
In Commercial Distribution

  • 08719425503264 ()


  • Dental veneer, professional
  • Dental bridge, polymer
  • Temporary dental crown/bridge
  • Temporary dental crown/bridge resin
  • Dental prosthesis veneer resin
  • Custom-made dental crown, polymer
‘B’ Base AMALGAMBOND® 5ml.
PARKELL, INC.
S372
Not in Commercial Distribution

  • M595S3720 ()
S372

  • Dentine bonding agent/set
ACHIEVECAS POINTER PROBE B BLUNT
Smith & Nephew, Inc.
74451018
Not in Commercial Distribution

  • 03596010592835 ()
74451018

  • Stereotactic surgery system probe, reusable
Ascend TL VBR Instruments B
ALPHATEC SPINE, INC.
ASTVBRAB
In Commercial Distribution

  • 00190376544885 ()


  • Instrument tray, reusable
PELVIC REDUCTION INSTRUMENT TRAY B
Smith & Nephew, Inc.
71174107
In Commercial Distribution

  • 03596010457356 ()
71174107

  • Instrument tray, reusable
DYONICS POWER INTERFACE CABLE B
Smith & Nephew, Inc.
72203139
In Commercial Distribution

  • 03596010653024 ()
72203139

  • Electrical-only medical device connection cable, reusable
ROL VST60SF B AIM TK
MAQUET SAS
ARDROL309038A
Not in Commercial Distribution

  • 03700712419257 ()


  • Mobile examination/treatment room light
ROL VST40SF B AIM TK
MAQUET SAS
ARDROL309037A
Not in Commercial Distribution

  • 03700712419240 ()


  • Mobile examination/treatment room light
ROL PWDII70SF CL K4 B
MAQUET SAS
ARDROL309050A
In Commercial Distribution

  • 03700712422813 ()


  • Mobile examination/treatment room light
ROL PWDII50SF CL K4 B
MAQUET SAS
ARDROL309048A
In Commercial Distribution

  • 03700712422790 ()


  • Mobile examination/treatment room light
ROL PWDII70SF CL K3 B
MAQUET SAS
ARDROL309046A
In Commercial Distribution

  • 03700712422776 ()


  • Mobile examination/treatment room light
ROL PWDII50SF CL K3 B
MAQUET SAS
ARDROL309044A
In Commercial Distribution

  • 03700712422752 ()


  • Mobile examination/treatment room light
MINI TRAVEL B/O TOOTHBRUSH
FOURSTAR GROUP INC.
64431566F
In Commercial Distribution

  • 00049696880145 ()


  • Ionic electric toothbrush
CLICK FLWMTR,O2,0-25LPM,PURT/B
Allied Medical, LLC
12510-PB-D
In Commercial Distribution

  • 00026072020814 ()


  • Medical gas flowmeter, dial-type
CLICK FLWMTR,O2,0-4LPM,P/B
Allied Medical, LLC
10410-PB-D
In Commercial Distribution

  • 00026072020616 ()


  • Medical gas flowmeter, Thorpe tube
ARCHES MEMORIA shape B 19x25
LEONE SPA
C6145-919
In Commercial Distribution

  • 08033707006657 ()
C6145-919

  • Orthodontic archwire
ARCHES MEMORIA shape B 19x25
LEONE SPA
C6145-19
In Commercial Distribution

  • 08033707006640 ()
C6145-19

  • Orthodontic archwire
ARCHES MEMORIA shape B 17x25
LEONE SPA
C6142-917
In Commercial Distribution

  • 08033707006596 ()
C6142-917

  • Orthodontic archwire
ARCHES MEMORIA shape B 16x22
LEONE SPA
C6142-916
In Commercial Distribution

  • 08033707006589 ()
C6142-916

  • Orthodontic archwire
ARCHES MEMORIA shape B 17x25
LEONE SPA
C6142-17
In Commercial Distribution

  • 08033707006572 ()
C6142-17

  • Orthodontic archwire
ARCHES MEMORIA shape B 16x22
LEONE SPA
C6142-16
In Commercial Distribution

  • 08033707006565 ()
C6142-16

  • Orthodontic archwire
ARCHES MEMORIA shape B 16x16
LEONE SPA
C6141-916
In Commercial Distribution

  • 08033707006534 ()
C6141-916

  • Orthodontic archwire
ARCHES MEMORIA shape B 16x16
LEONE SPA
C6141-16
In Commercial Distribution

  • 08033707006527 ()
C6141-16

  • Orthodontic archwire
ARCHES MEMORIA shape B 18
LEONE SPA
C6140-918
In Commercial Distribution

  • 08033707006459 ()
C6140-918

  • Orthodontic archwire
ARCHES MEMORIA shape B 16
LEONE SPA
C6140-916
In Commercial Distribution

  • 08033707006442 ()
C6140-916

  • Orthodontic archwire
ARCHES MEMORIA shape B 14
LEONE SPA
C6140-914
In Commercial Distribution

  • 08033707006435 ()
C6140-914

  • Orthodontic archwire
ARCHES MEMORIA shape B 18
LEONE SPA
C6140-18
In Commercial Distribution

  • 08033707006428 ()
C6140-18

  • Orthodontic archwire
ARCHES MEMORIA shape B 16
LEONE SPA
C6140-16
In Commercial Distribution

  • 08033707006411 ()
C6140-16

  • Orthodontic archwire
ARCHES MEMORIA shape B 14
LEONE SPA
C6140-14
In Commercial Distribution

  • 08033707006404 ()
C6140-14

  • Orthodontic archwire
Kodiak OPEN CORE B Instruments
ALPHATEC SPINE, INC.
KDOCORB
In Commercial Distribution

  • 00190376275833 ()


  • Instrument tray, reusable
Kodiak MIS CORE B Instruments
ALPHATEC SPINE, INC.
KDMCORB
In Commercial Distribution

  • 00190376275727 ()


  • Instrument tray, reusable
Battalion LLIF, OFFSET INSTRUMENTS B
ALPHATEC SPINE, INC.
LATOFFB
In Commercial Distribution

  • 00190376275994 ()


  • Instrument tray, reusable
Battalion LLIF, GENERAL INSTRUMENTS B
ALPHATEC SPINE, INC.
LATGENB
In Commercial Distribution

  • 00190376275963 ()


  • Instrument tray, reusable
Expansion Module B 14x20, 5°
NEXT ORTHOSURGICAL, INC.
9076-14-20-5-B-HA
In Commercial Distribution

  • 00840314193636 ()

  • Length: 20 Millimeter
  • Angle: 5 degree
9076-14-20-5-B-HA

  • Vertebral body prosthesis
Expansion Module B 13x20, 5°
NEXT ORTHOSURGICAL, INC.
9076-13-20-5-B-HA
In Commercial Distribution

  • 00840314193629 ()

  • Length: 20 Millimeter
  • Angle: 5 degree
9076-13-20-5-B-HA

  • Vertebral body prosthesis
Expansion Module B 12x20, 5°
NEXT ORTHOSURGICAL, INC.
9076-12-20-5-B-HA
In Commercial Distribution

  • 00840314193612 ()

  • Length: 20 Millimeter
  • Angle: 5 degree
9076-12-20-5-B-HA

  • Vertebral body prosthesis
Expansion Module B 11x20, 5°
NEXT ORTHOSURGICAL, INC.
9076-11-20-5-B-HA
In Commercial Distribution

  • 00840314193605 ()

  • Length: 20 Millimeter
  • Angle: 5 degree
9076-11-20-5-B-HA

  • Vertebral body prosthesis
Expansion Module B 10x20, 5°
NEXT ORTHOSURGICAL, INC.
9076-10-20-5-B-HA
In Commercial Distribution

  • 00840314193599 ()

  • Length: 20 Millimeter
  • Angle: 5 degree
9076-10-20-5-B-HA

  • Vertebral body prosthesis
Expansion Module B 9x20, 5°
NEXT ORTHOSURGICAL, INC.
9076-09-20-5-B-HA
In Commercial Distribution

  • 00840314193582 ()

  • Length: 20 Millimeter
  • Angle: 5 degree
9076-09-20-5-B-HA

  • Vertebral body prosthesis
Expansion Module B 8x20, 5°
NEXT ORTHOSURGICAL, INC.
9076-08-20-5-B-HA
In Commercial Distribution

  • 00840314193575 ()

  • Length: 20 Millimeter
  • Angle: 5 degree
9076-08-20-5-B-HA

  • Vertebral body prosthesis
Expansion Module B 7x20, 5°
NEXT ORTHOSURGICAL, INC.
9076-07-20-5-B-HA
In Commercial Distribution

  • 00840314193568 ()

  • Length: 20 Millimeter
  • Angle: 5 degree
9076-07-20-5-B-HA

  • Vertebral body prosthesis
Expansion Module B 14x20, 0°
NEXT ORTHOSURGICAL, INC.
9076-14-20-0-B-HA
In Commercial Distribution

  • 00840314193551 ()

  • Length: 20 Millimeter
  • Angle: 0 degree
9076-14-20-0-B-HA

  • Vertebral body prosthesis
Expansion Module B 13x20, 0°
NEXT ORTHOSURGICAL, INC.
9076-13-20-0-B-HA
In Commercial Distribution

  • 00840314193544 ()

  • Length: 20 Millimeter
  • Angle: 0 degree
9076-13-20-0-B-HA

  • Vertebral body prosthesis
Expansion Module B 12x20, 0°
NEXT ORTHOSURGICAL, INC.
9076-12-20-0-B-HA
In Commercial Distribution

  • 00840314193537 ()

  • Length: 20 Millimeter
  • Angle: 0 degree
9076-12-20-0-B-HA

  • Vertebral body prosthesis
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