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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Nitrile Exam Glove, Black, X-Large
Dash Medical Gloves, Inc.
BMNT200XL
In Commercial Distribution

  • 00649531141174 ()
  • 00649531041177 ()
  • 00649531041078 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Nitrile Exam Glove, Black, Large
Dash Medical Gloves, Inc.
BMNT200L
In Commercial Distribution

  • 00649531141167 ()
  • 00649531041160 ()
  • 00649531041061 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Nitrile Exam Glove, Black, Medium
Dash Medical Gloves, Inc.
BMNT200M
In Commercial Distribution

  • 00649531141143 ()
  • 00649531041146 ()
  • 00649531041047 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Nitrile Exam Glove, Black, Small
Dash Medical Gloves, Inc.
BMNT200S
In Commercial Distribution

  • 00649531141129 ()
  • 00649531041122 ()
  • 00649531041023 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Nitrile Exam Glove, Black, X-Small
Dash Medical Gloves, Inc.
BMNT200XS
In Commercial Distribution

  • 00649531141112 ()
  • 00649531041115 ()
  • 00649531041016 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Nitrile Exam Glove, Black, XX-Large
Dash Medical Gloves, Inc.
BMN100XXL
In Commercial Distribution

  • 00649531140184 ()
  • 00649531040187 ()
  • 00649531040088 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Nitrile Exam Glove, Black, X-Large
Dash Medical Gloves, Inc.
BMN100XL
In Commercial Distribution

  • 00649531140177 ()
  • 00649531040170 ()
  • 00649531040071 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Nitrile Exam Glove, Black, Large
Dash Medical Gloves, Inc.
BMN100L
In Commercial Distribution

  • 00649531140160 ()
  • 00649531040163 ()
  • 00649531040064 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Nitrile Exam Glove, Black, Medium
Dash Medical Gloves, Inc.
BMN100M
In Commercial Distribution

  • 00649531140146 ()
  • 00649531040149 ()
  • 00649531040040 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Nitrile Exam Glove, Black, Small
Dash Medical Gloves, Inc.
BMN100S
In Commercial Distribution

  • 00649531140122 ()
  • 00649531040125 ()
  • 00649531040026 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Latex Exam Glove, Black, X-Large
Dash Medical Gloves, Inc.
BMX100XL
In Commercial Distribution

  • 00649531130178 ()
  • 00649531030171 ()
  • 00649531030072 ()


  • Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial
Latex Exam Glove, Black, Large
Dash Medical Gloves, Inc.
BMX100L
In Commercial Distribution

  • 00649531130161 ()
  • 00649531030164 ()
  • 00649531030065 ()


  • Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial
Latex Exam Glove, Black, Medium
Dash Medical Gloves, Inc.
BMX100M
In Commercial Distribution

  • 00649531130147 ()
  • 00649531030140 ()
  • 00649531030041 ()


  • Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial
Latex Exam Glove, Black, Small
Dash Medical Gloves, Inc.
BMX100S
In Commercial Distribution

  • 00649531130123 ()
  • 00649531030126 ()
  • 00649531030027 ()


  • Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial
Latex Exam Glove, Black, X-Small
Dash Medical Gloves, Inc.
BMX100XS
In Commercial Distribution

  • 00649531130116 ()
  • 00649531030119 ()
  • 00649531030010 ()


  • Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial
1" BLACK POLY ACCESSORY STRAP
MORRISON MEDICAL, LTD
CEMSAR1355A
In Commercial Distribution

  • 00647921835559 ()
CEMSAR1355A

  • Limb/torso/head restraint, reusable
GROMMETED BLACK FLAT MAT
MORRISON MEDICAL, LTD
6730
In Commercial Distribution

  • 00647921673007 ()
6730

  • General-purpose patient lifting system sling/harness
REGULAR BLACK. 30 X 70",EA.
MORRISON MEDICAL, LTD
3010BK
In Commercial Distribution

  • 00647921301023 ()
3010BK

  • General-purpose patient lifting system sling/harness
HEAD IMMOBILIZER BLACK, CS/6
MORRISON MEDICAL, LTD
1420BK-6
In Commercial Distribution

  • 00647921142060 ()
  • 00647921142114 ()
1420BK-6

  • Head/neck immobilizer, reusable
An all-tissue dental laser system intended for a variety of soft-tissue and hard-tissue procedures. The system includes a laser console with a touch screen control panel/user interface, a delivery system comprising of a fiber optic cable, two handpieces and laser tips, a wired footswitch, and other accessories (power cords, protective eyewear, tip cleaning kit). The patient-contacting components of the delivery system require sterilization prior to use.
Biolase, Inc.
All tissue YSGG dental laser system, gloss black premier
In Commercial Distribution

  • 00647529004364 ()
7200854-203

  • Dental solid-state laser system
An all-tissue dental laser system intended for a variety of soft-tissue and hard-tissue procedures. The system includes a laser console with a touch screen control panel/user interface, a delivery system comprising of a fiber optic cable, two handpieces and laser tips, a wired footswitch, and other accessories (power cords, protective eyewear, tip cleaning kit). The patient-contacting components of the delivery system require sterilization prior to use.
Biolase, Inc.
All tissue YSGG dental laser system, gloss black w/ C&V indication
In Commercial Distribution

  • 00647529003855 ()
7200854-03

  • Dental solid-state laser system
NeoCheck Disposable Blood Pressure Cuff Neonatal (6-11cm) - Double Tube 7-24-2020 original Primary DI above was entered in error. The correct DI is 00607411911415.
SALTER LABS
ZNC4702L-1
Not in Commercial Distribution

  • 00647011911415 ()

  • Neonatal
ZNC4702L-1..

  • Blood pressure cuff, single-use
No Description
M3 Global Enterprises, LLC
Royal Black Grape Condoms Box of 3
Not in Commercial Distribution

  • 00646437668897 ()


  • Basic male condom, Hevea-latex
No Description
M3 Global Enterprises, LLC
Royal Black Grape Condoms Box of 10
Not in Commercial Distribution

  • 00646437668859 ()


  • Basic male condom, Hevea-latex
TEARDROP TIP, BLACK FINISH
PMT CORPORATION
3201-12T-09-BF
Not in Commercial Distribution

  • 00650551028369 ()

  • Length: 9 Inch
  • Catheter Gauge: 12 French
3201-12T-09-BF

  • Surgical irrigation/aspiration handpiece, reusable
TEARDROP TIP, BLACK FINISH
PMT CORPORATION
3201-12T-06-BF
Not in Commercial Distribution

  • 00650551028338 ()

  • Catheter Gauge: 12 French
  • Length: 6 Inch
3201-12T-06-BF

  • Surgical irrigation/aspiration handpiece, reusable
TEARDROP TIP, BLACK FINISH
PMT CORPORATION
3201-12T-03-BF
Not in Commercial Distribution

  • 00650551028307 ()

  • Length: 3 Inch
  • Catheter Gauge: 12 French
3201-12T-03-BF

  • Surgical irrigation/aspiration handpiece, reusable
SLOTTED TIP, BLACK FINISH
PMT CORPORATION
3201-12S-09-BF
Not in Commercial Distribution

  • 00650551028277 ()

  • Catheter Gauge: 12 French
  • Length: 9 Inch
3201-12S-09-BF

  • Surgical irrigation/aspiration handpiece, reusable
SLOTTED TIP, BLACK FINISH
PMT CORPORATION
3201-12S-06-BF
Not in Commercial Distribution

  • 00650551028246 ()

  • Length: 6 Inch
  • Catheter Gauge: 12 French
3201-12S-06-BF

  • Surgical irrigation/aspiration handpiece, reusable
SLOTTED TIP, BLACK FINISH
PMT CORPORATION
3201-12S-03-BF
Not in Commercial Distribution

  • 00650551028215 ()

  • Catheter Gauge: 12 French
  • Length: 3 Inch
3201-12S-03-BF

  • Surgical irrigation/aspiration handpiece, reusable
PORTED TIP, BLACK FINISH
PMT CORPORATION
3201-12P-09-BF
Not in Commercial Distribution

  • 00650551028185 ()

  • Catheter Gauge: 12 French
  • Length: 9 Inch
3201-12P-09-BF

  • Surgical irrigation/aspiration handpiece, reusable
PORTED TIP, BLACK FINISH
PMT CORPORATION
3201-12P-06-BF
Not in Commercial Distribution

  • 00650551028154 ()

  • Length: 6 Inch
  • Catheter Gauge: 12 French
3201-12P-06-BF

  • Surgical irrigation/aspiration handpiece, reusable
PORTED TIP, BLACK FINISH
PMT CORPORATION
3201-12P-03-BF
Not in Commercial Distribution

  • 00650551028123 ()

  • Catheter Gauge: 12 French
  • Length: 3 Inch
3201-12P-03-BF

  • Surgical irrigation/aspiration handpiece, reusable
MEDIUM TIP, BLACK FINISH
PMT CORPORATION
3201-12M-09-BF
Not in Commercial Distribution

  • 00650551028093 ()

  • Catheter Gauge: 12 French
  • Length: 9 Inch
3201-12M-09-BF

  • Surgical irrigation/aspiration handpiece, reusable
MEDIUM TIP, BLACK FINISH
PMT CORPORATION
3201-12M-06-BF
Not in Commercial Distribution

  • 00650551028062 ()

  • Length: 6 Inch
  • Catheter Gauge: 12 French
3201-12M-06-BF

  • Surgical irrigation/aspiration handpiece, reusable
MEDIUM TIP, BLACK FINISH
PMT CORPORATION
3201-12M-03-BF
Not in Commercial Distribution

  • 00650551028031 ()

  • Catheter Gauge: 12 French
  • Length: 3 Inch
3201-12M-03-BF

  • Surgical irrigation/aspiration handpiece, reusable
TEARDROP TIP, BLACK FINISH
PMT CORPORATION
3201-09T-09-BF
Not in Commercial Distribution

  • 00650551028000 ()

  • Catheter Gauge: 9 French
  • Length: 9 Inch
3201-09T-09-BF

  • Surgical irrigation/aspiration handpiece, reusable
TEARDROP TIP, BLACK FINISH
PMT CORPORATION
3201-09T-06-BF
Not in Commercial Distribution

  • 00650551027973 ()

  • Length: 6 Inch
  • Catheter Gauge: 9 French
3201-09T-06-BF

  • Surgical irrigation/aspiration handpiece, reusable
TEARDROP TIP, BLACK FINISH
PMT CORPORATION
3201-09T-03-BF
Not in Commercial Distribution

  • 00650551027942 ()

  • Catheter Gauge: 9 French
  • Length: 3 Inch
3201-09T-03-BF

  • Surgical irrigation/aspiration handpiece, reusable
SLOTTED TIP, BLACK FINISH
PMT CORPORATION
3201-09S-09-BF
Not in Commercial Distribution

  • 00650551027911 ()

  • Length: 9 Inch
  • Catheter Gauge: 9 French
3201-09S-09-BF

  • Surgical irrigation/aspiration handpiece, reusable
SLOTTED TIP, BLACK FINISH
PMT CORPORATION
3201-09S-06-BF
Not in Commercial Distribution

  • 00650551027881 ()

  • Catheter Gauge: 9 French
  • Length: 6 Inch
3201-09S-06-BF

  • Surgical irrigation/aspiration handpiece, reusable
SLOTTED TIP, BLACK FINISH
PMT CORPORATION
3201-09S-03-BF
Not in Commercial Distribution

  • 00650551027850 ()

  • Length: 3 Inch
  • Catheter Gauge: 9 French
3201-09S-03-BF

  • Surgical irrigation/aspiration handpiece, reusable
PORTED TIP, BLACK FINISH
PMT CORPORATION
3201-09P-09-BF
Not in Commercial Distribution

  • 00650551027829 ()

  • Length: 9 Inch
  • Catheter Gauge: 9 French
3201-09P-09-BF

  • Surgical irrigation/aspiration handpiece, reusable
PORTED TIP, BLACK FINISH
PMT CORPORATION
3201-09P-06-BF
Not in Commercial Distribution

  • 00650551027799 ()

  • Catheter Gauge: 9 French
  • Length: 6 Inch
3201-09P-06-BF

  • Surgical irrigation/aspiration handpiece, reusable
PORTED TIP, BLACK FINISH
PMT CORPORATION
3201-09P-03-BF
Not in Commercial Distribution

  • 00650551027768 ()

  • Length: 3 Inch
  • Catheter Gauge: 9 French
3201-09P-03-BF

  • Surgical irrigation/aspiration handpiece, reusable
MEDIUM TIP, BLACK FINISH
PMT CORPORATION
3201-09M-4.5-BF
Not in Commercial Distribution

  • 00650551027744 ()

  • Length: 4.5 Inch
  • Catheter Gauge: 9 French
3201-09M-4.5-BF

  • Surgical irrigation/aspiration handpiece, reusable
MEDIUM TIP, BLACK FINISH
PMT CORPORATION
3201-09M-09-BF
Not in Commercial Distribution

  • 00650551027713 ()

  • Catheter Gauge: 9 French
  • Length: 9 Inch
3201-09M-09-BF

  • Surgical irrigation/aspiration handpiece, reusable
MEDIUM TIP, BLACK FINISH
PMT CORPORATION
3201-09M-06-BF
Not in Commercial Distribution

  • 00650551027683 ()

  • Length: 6 Inch
  • Catheter Gauge: 9 French
3201-09M-06-BF

  • Surgical irrigation/aspiration handpiece, reusable
MEDIUM TIP, BLACK FINISH
PMT CORPORATION
3201-09M-03-BF
Not in Commercial Distribution

  • 00650551027652 ()

  • Catheter Gauge: 9 French
  • Length: 3 Inch
3201-09M-03-BF

  • Surgical irrigation/aspiration handpiece, reusable
TEARDROP TIP, BLACK FINISH
PMT CORPORATION
3201-07T-09-BF
Not in Commercial Distribution

  • 00650551027621 ()

  • Length: 9 Inch
  • Catheter Gauge: 7 French
3201-07T-09-BF

  • Surgical irrigation/aspiration handpiece, reusable
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