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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For Contraception Plus STI Protection
B HOLDING GROUP LLC
Ribbed b condoms
In Commercial Distribution

  • 00850281004330 ()
  • 00850281004538 ()


  • Basic male condom, Hevea-latex
For Contraception Plus STI Protection
B HOLDING GROUP LLC
Platinum b condoms
In Commercial Distribution

  • 00850281004460 ()
  • 00850281004514 ()


  • Basic male condom, Hevea-latex
For Contraception Plus STI Protection
B HOLDING GROUP LLC
Platinum b condoms
In Commercial Distribution

  • 00850281004453 ()
  • 00850281004491 ()


  • Basic male condom, Hevea-latex
For Contraception Plus STI Protection
B HOLDING GROUP LLC
Platinum XL b condoms
In Commercial Distribution

  • 00850281004156 ()
  • 00850281004262 ()


  • Basic male condom, Hevea-latex
For Contraception Plus STI Protection
B HOLDING GROUP LLC
Classic b condoms
In Commercial Distribution

  • 00850281004187 ()
  • 00850281004255 ()


  • Basic male condom, Hevea-latex
For Contraception Plus STI Protection
B HOLDING GROUP LLC
Platinum XL b condoms
In Commercial Distribution

  • 00850281004095 ()
  • 00850281004248 ()


  • Basic male condom, Hevea-latex
For Contraception Plus STI Protection
B HOLDING GROUP LLC
Classic b condoms
In Commercial Distribution

  • 00850281004088 ()
  • 00850281004224 ()


  • Basic male condom, Hevea-latex
Metal Lined Cermic Twin ROTH .018 LL3 -11°T +5°A 5PK
Flexmedics
50-L3-8L-V
In Commercial Distribution

  • 00195291003776 ()
  • 10195291003773 ()


  • Orthodontic bracket, ceramic
No Description
BIOCARE MEDICAL LLC
ACI3202A
In Commercial Distribution

  • 00847627003607 ()


  • Lactoferrin IVD, antibody
The product is intended to be used as a second Calibrator in a two-point calibration. Calibrator B is aspirated from a sample cup at position 18 on the analyser ASP tray at least once every 8 hours depending on the laboratories schedule.
RANDOX LABORATORIES LIMITED
RX3949
In Commercial Distribution

  • 05055273205954 ()
RX3949

  • Multiple-type clinical chemistry analyte profile IVD, calibrator
No Description
Shandong Weigao Orthopaedic Device Co., Ltd.
8483001
In Commercial Distribution

  • 06912547143888 ()


  • Bone-screw internal spinal fixation system rod
No Description
Shandong Weigao Orthopaedic Device Co., Ltd.
8483006
In Commercial Distribution

  • 06912547143871 ()


  • Bone-screw internal spinal fixation system rod
No Description
Shandong Weigao Orthopaedic Device Co., Ltd.
8482011
In Commercial Distribution

  • 06912547143864 ()


  • Bone-screw internal spinal fixation system rod
No Description
Shandong Weigao Orthopaedic Device Co., Ltd.
8482012
In Commercial Distribution

  • 06912547143857 ()


  • Bone-screw internal spinal fixation system rod
No Description
Beijing M&B Electronic Instruments Co., Ltd.
MSA100BT
In Commercial Distribution

  • 06922649905055 ()


  • Expiratory peak flow meter, digital
No Description
Beijing M&B Electronic Instruments Co., Ltd.
MSA100
In Commercial Distribution

  • 06922649905048 ()


  • Expiratory peak flow meter, digital
ZYM B is a reagent associated to API® Listeria (10 300), API® NH (10 400), API® Staph (20 500), API® 20 Strep (20 600), API® Coryne (20 900), API® ZYM (25 200)
BIOMERIEUX SA
70493
In Commercial Distribution

  • 03573026141998 ()


  • Multiple Staphylococcus bacterial species culture isolate identification IVD, kit
Heat Source, Model 1005
ORMCO CORPORATION
952-0001
In Commercial Distribution

  • 00889989068412 ()


  • Endodontic filling material condenser
No Description
Oscor Inc.
B/IS-15
Not in Commercial Distribution

  • 00836559002666 ()
B/IS-15

  • Pacing/defibrillation lead electrical adaptor
JADE GUA SHA
FOURSTAR GROUP INC.
64431580
In Commercial Distribution

  • 00049696896214 ()


  • External manual massager, home-use
MINI JADE ROLLER
FOURSTAR GROUP INC.
64431580
In Commercial Distribution

  • 00049696896207 ()


  • External manual massager, home-use
PINEAPPLE SILICONE TEETHER
FOURSTAR GROUP INC.
64410081
In Commercial Distribution

  • 00049696889995 ()


  • Teething device, non-fluid-filled
Mask with Nebulizer
Allied Medical, LLC
64085
In Commercial Distribution

  • 00026072023495 ()


  • Benchtop nebulizer, non-heated
Nebulizer
Allied Medical, LLC
61402-BB2
In Commercial Distribution

  • 00026072011140 ()
  • 40026072011148 ()


  • Benchtop nebulizer, non-heated
Nebulizer
Allied Medical, LLC
61401
In Commercial Distribution

  • 00026072011126 ()
  • 40026072011124 ()


  • Benchtop nebulizer, non-heated
Nebulizer Kit
Allied Medical, LLC
61400-SF
In Commercial Distribution

  • 00026072011119 ()


  • Benchtop nebulizer, non-heated
Nebulizer Kit
Allied Medical, LLC
61400
In Commercial Distribution

  • 00026072011096 ()
  • 40026072011094 ()


  • Benchtop nebulizer, non-heated
Nebulizer Kit
Allied Medical, LLC
61399
In Commercial Distribution

  • 00026072011072 ()
  • 40026072011070 ()


  • Benchtop nebulizer, non-heated
Humidifier
Allied Medical, LLC
64378
In Commercial Distribution

  • 00026072011256 ()
  • 40026072011254 ()


  • Non-heated respiratory humidifier
Humidifier
Allied Medical, LLC
64377
In Commercial Distribution

  • 00026072011249 ()
  • 40026072011247 ()


  • Non-heated respiratory humidifier
Humidifier
Allied Medical, LLC
64376
In Commercial Distribution

  • 00026072011232 ()
  • 40026072011230 ()


  • Non-heated respiratory humidifier
Humidifier
Allied Medical, LLC
64375
In Commercial Distribution

  • 00026072011225 ()
  • 40026072011223 ()


  • Non-heated respiratory humidifier
Mask, Ped Aerosol Neb
Allied Medical, LLC
64095
In Commercial Distribution

  • 00026072011218 ()
  • 40026072011216 ()


  • Benchtop nebulizer, non-heated
Nebulizer Kit
Allied Medical, LLC
61406
In Commercial Distribution

  • 00026072011188 ()
  • 40026072011186 ()


  • Benchtop nebulizer, non-heated
Nebulizer Kit
Allied Medical, LLC
61405
In Commercial Distribution

  • 00026072011171 ()
  • 40026072011179 ()


  • Benchtop nebulizer, non-heated
Nebulizer Kit
Allied Medical, LLC
61403
In Commercial Distribution

  • 00026072011157 ()
  • 40026072011155 ()


  • Benchtop nebulizer, non-heated
Nebulizer
Allied Medical, LLC
61402-BB
In Commercial Distribution

  • 00026072011133 ()
  • 40026072011131 ()


  • Benchtop nebulizer, non-heated
Nebulizer Set
Allied Medical, LLC
61400-2
In Commercial Distribution

  • 00026072011102 ()
  • 40026072011100 ()


  • Benchtop nebulizer, non-heated
Nebulizer Kit
Allied Medical, LLC
61399-SF
In Commercial Distribution

  • 00026072011089 ()
  • 40026072011087 ()


  • Benchtop nebulizer, non-heated
Biopsy needle for automatic gun 20G; 15cm
STERYLAB SRL
FAST-CUT B
In Commercial Distribution

  • 18033959224547 ()
  • 08033959224540 ()
FSC2015B

  • End-cut biopsy gun needle
Biopsy needle for automatic gun 18G; 25cm
STERYLAB SRL
FAST-CUT B
In Commercial Distribution

  • 18033959224448 ()
  • 08033959224441 ()
FSC1825B

  • End-cut biopsy gun needle
Biopsy needle for automatic gun 18G; 20cm
STERYLAB SRL
FAST-CUT B
In Commercial Distribution

  • 18033959224400 ()
  • 08033959224403 ()
FSC1820B

  • End-cut biopsy gun needle
Biopsy needle for automatic gun 18G; 15cm
STERYLAB SRL
FAST-CUT B
In Commercial Distribution

  • 18033959224356 ()
  • 08033959224359 ()
FSC1815B

  • End-cut biopsy gun needle
Biopsy needle for automatic gun 16G; 25cm
STERYLAB SRL
FAST-CUT B
In Commercial Distribution

  • 18033959224257 ()
  • 08033959224250 ()
FSC1625B

  • End-cut biopsy gun needle
Biopsy needle for automatic gun 16G; 20cm
STERYLAB SRL
FAST-CUT B
In Commercial Distribution

  • 18033959224219 ()
  • 08033959224212 ()
FSC1620B

  • End-cut biopsy gun needle
Biopsy needle for automatic gun 16G; 15cm
STERYLAB SRL
FAST-CUT B
In Commercial Distribution

  • 18033959224165 ()
  • 08033959224168 ()
FSC1615B

  • End-cut biopsy gun needle
Biopsy needle for automatic gun 14G; 25cm
STERYLAB SRL
FAST-CUT B
In Commercial Distribution

  • 18033959224035 ()
  • 08033959224038 ()
FSC1425B

  • End-cut biopsy gun needle
Biopsy needle for automatic gun 20G; 25cm
STERYLAB SRL
FAST-CUT B
In Commercial Distribution

  • 18033959220686 ()
  • 08033959220689 ()
FSC2025B

  • End-cut biopsy gun needle
Biopsy needle for automatic gun 20G; 20cm
STERYLAB SRL
FAST-CUT B
In Commercial Distribution

  • 18033959220679 ()
  • 08033959220672 ()
FSC2020B

  • End-cut biopsy gun needle
Biopsy needle for automatic gun 14G; 20cm
STERYLAB SRL
FAST-CUT B
In Commercial Distribution

  • 18033959220259 ()
  • 08033959220252 ()
FSC1420B

  • End-cut biopsy gun needle
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