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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COE® Regular-Perforated Individual tray, #1 Upper XL
Gc America Inc.
260011
In Commercial Distribution

  • D6582600112 ()
  • D6582600111 ()
  • D6582600114 ()
260011

  • Dental impression tray, reusable
COE® SPACER TRAYS #32D Anterior Perforated-Partial
Gc America Inc.
250321
In Commercial Distribution

  • D6582503262 ()
  • D6582503211 ()
  • D6582532124 ()
  • D6582503210 ()
250321

  • Dental impression tray, single-use
COE® SPACER TRAYS #31D Upper R, Lower L Perforated-Partial
Gc America Inc.
250311
In Commercial Distribution

  • D6582503162 ()
  • D6582503111 ()
  • D6582531124 ()
  • D6582503110 ()
250311

  • Dental impression tray, single-use
COE® SPACER TRAYS #30D Upper L, Lower R Perforated-Partial
Gc America Inc.
250301
In Commercial Distribution

  • D6582503062 ()
  • D6582503011 ()
  • D6582530124 ()
  • D6582503010 ()
250301

  • Dental impression tray, single-use
COE® SPACER TRAYS #22D Small Lower Perforated
Gc America Inc.
250221
In Commercial Distribution

  • D6582502262 ()
  • D6582502211 ()
  • D6582522124 ()
  • D6582502210 ()
250221

  • Dental impression tray, single-use
COE® SPACER TRAYS #21D Medium Lower Perforated
Gc America Inc.
250211
In Commercial Distribution

  • D6582502162 ()
  • D6582502111 ()
  • D6582521124 ()
  • D6582502110 ()
250211

  • Dental impression tray, single-use
COE® SPACER TRAYS #20D Large Lower Perforated
Gc America Inc.
250201
In Commercial Distribution

  • D6582520124 ()
  • D6582502062 ()
  • D6582502011 ()
  • D6582502010 ()
250201

  • Dental impression tray, single-use
COE® SPACER TRAYS Perforated Assorted Package
Gc America Inc.
250096
In Commercial Distribution

  • D6582500962 ()
  • D6582500961 ()
  • D6582501124 ()
  • D6582500960 ()
250096

  • Dental impression tray, single-use
COE® SPACER TRAYS #7D Small Upper Perforated
Gc America Inc.
250071
In Commercial Distribution

  • D6582500762 ()
  • D6582500711 ()
  • D6582507124 ()
  • D6582500710 ()
250071

  • Dental impression tray, single-use
COE® SPACER TRAYS #4D Medium Upper Perforated
Gc America Inc.
250041
In Commercial Distribution

  • D6582500462 ()
  • D6582500411 ()
  • D6582504124 ()
  • D6582500410 ()
250041

  • Dental impression tray, single-use
COE® SPACER TRAYS #1D Large Upper Perforated
Gc America Inc.
250011
In Commercial Distribution

  • D6582500124 ()
  • D6582500162 ()
  • D6582500111 ()
  • D6582500110 ()
250011

  • Dental impression tray, single-use
Light Reddish Pink
Dentsply International Inc.
50-Unit Package
In Commercial Distribution

  • D0019059441 ()
  • D0019059340 ()
  • D0019060202 ()

  • Weight: 1000 Gram
905934

  • Dental appliance fabrication material, resin
Original Opaque
Dentsply International Inc.
50-Unit Package
In Commercial Distribution

  • D0019059561 ()
  • D0019059540 ()
  • D0019060222 ()

  • Weight: 1000 Gram
905954

  • Dental appliance fabrication material, resin
Dark Pink
Dentsply International Inc.
50-Unit Package
In Commercial Distribution

  • D0019060212 ()
  • D0019059451 ()
  • D0019059350 ()

  • Weight: 1000 Gram
905935

  • Dental appliance fabrication material, resin
Light
Dentsply International Inc.
50-Unit Package
In Commercial Distribution

  • D0019060192 ()
  • D0019059431 ()
  • D0019059330 ()

  • Weight: 1000 Gram
905933

  • Dental appliance fabrication material, resin
Original
Dentsply International Inc.
50-Unit Package
In Commercial Distribution

  • D0019059421 ()
  • D0019059320 ()
  • D0019060182 ()

  • Weight: 1000 Gram
905932

  • Dental appliance fabrication material, resin
DRUGS OF ABUSE LEVEL 3
UTAK LABORATORIES, INC.
DAU 3 V2 F U VMG
In Commercial Distribution

  • B800DAU3V2FUVMG0 ()
  • B800DAU3V2FUVMG05 ()
  • B800DAU3V2FUVMG5 ()

  • Total Volume: 10 Milliliter
DAU 3 V2 F U VMG

  • Multiple drugs of abuse IVD, control
BUSULFAN 25 NG/ML
UTAK LABORATORIES, INC.
BUS 25 V P F CHLA
In Commercial Distribution

  • B800BUS25VPFCHLA5 ()
  • B800BUS25VPFCHLA0 ()
  • B800BUS25VPFCHLA55 ()

  • Total Volume: 5 Milliliter
BUS 25 V P F CHLA

  • Multiple-type clinical chemistry analyte profile IVD, control
BUS 250 V P F CHLA
UTAK LABORATORIES, INC.
BUS 250 V P F CHLA
In Commercial Distribution

  • B800BUS250VPFCHLA5 ()
  • B800BUS250VPFCHLA0 ()
  • B800BUS250VPFCHLA55 ()

  • Total Volume: 5 Milliliter
BUS 250 V P F CHLA

  • Multiple-type clinical chemistry analyte profile IVD, control
BUSULFAN 10 NG/ML
UTAK LABORATORIES, INC.
BUS 10 V P F CHLA
In Commercial Distribution

  • B800BUS10VPFCHLA5 ()
  • B800BUS10VPFCHLA0 ()
  • B800BUS10VPFCHLA55 ()

  • Total Volume: 5 Milliliter
BUS 10 V P F CHLA

  • Multiple-type clinical chemistry analyte profile IVD, control
BUSULFAN 100 NG/ML
UTAK LABORATORIES, INC.
BUS 100 V P F CHLA
In Commercial Distribution

  • B800BUS100VPFCHLA5 ()
  • B800BUS100VPFCHLA0 ()
  • B800BUS100VPFCHLA55 ()

  • Total Volume: 5 Milliliter
BUS 100 V P F CHLA

  • Multiple-type clinical chemistry analyte profile IVD, control
BUSULFAN 1000 NG/ML
UTAK LABORATORIES, INC.
BUS 1000 V P F CHLA
In Commercial Distribution

  • B800BUS1000VPFCHLA5 ()
  • B800BUS1000VPFCHLA0 ()
  • B800BUS1000VPFCHLA55 ()

  • Total Volume: 5 Milliliter
BUS 1000 V P F CHLA

  • Multiple-type clinical chemistry analyte profile IVD, control
ACETONE BLANK
UTAK LABORATORIES, INC.
ACE BLK S F BSRHS
In Commercial Distribution

  • B800ACEBLKSFBSRHS5 ()
  • B800ACEBLKSFBSRHS0 ()
  • B800ACEBLKSFBSRHS55 ()

  • Total Volume: 1 Milliliter
ACE BLK S F BSRHS

  • Multiple-type clinical chemistry analyte profile IVD, control
Post-parturition vaginal retractor intended to retract the vaginal walls following childbirth for improved visualization and access during surgical repair (e.g. suturing) of vaginal tears.
Birch Concepts LLC
1001
In Commercial Distribution

  • B79510011 ()
  • B79510010 ()
  • B79510012 ()
1001

  • Post-parturition vaginal retractor
Patch for use with the SPEAX Communication System
ATAIA INC.
FGN-002
In Commercial Distribution

  • B792FGN003 ()
  • B792FGN002 ()
  • B792FGN012 ()
FGN002

  • Voice amplification system
A disposable cartridge and sample preparation tools for use with the Sight OLO CBC analyzer.
S.D. SIGHT DIAGNOSTICS LTD
TK1
In Commercial Distribution

  • B787TK10 ()
  • B787TK11 ()
  • B787TK12 ()


  • Full blood count IVD, kit, cell count
Nitrile Powder Free Medical Gloves Size Large
GD CARE INC.
CS-515
In Commercial Distribution

  • B754CS5151 ()
  • B754CS515 ()
  • B754CS5152 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Nitrile Powder Free Medical Gloves Size Medium
GD CARE INC.
CS-510
In Commercial Distribution

  • B754CS5101 ()
  • B754CS510 ()
  • B754CS5102 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
33G x 5/32" (4mm)
QUALITY MEDICAL PRODUCTS USA, INC.
335776
In Commercial Distribution

  • B7443357763 ()
  • B7443357762 ()
  • B7443357761 ()
  • B7443357760 ()


  • Autoinjector needle
32G X 5/32" (4mm)
QUALITY MEDICAL PRODUCTS USA, INC.
335774
In Commercial Distribution

  • B7443357743 ()
  • B7443357742 ()
  • B7443357741 ()
  • B7443357740 ()


  • Autoinjector needle
31G X 5/16" (8mm)
QUALITY MEDICAL PRODUCTS USA, INC.
335773
In Commercial Distribution

  • B7443357733 ()
  • B7443357732 ()
  • B7443357731 ()
  • B7443357730 ()


  • Autoinjector needle
31G X 3/16" (5mm)
QUALITY MEDICAL PRODUCTS USA, INC.
335772
In Commercial Distribution

  • B7443357723 ()
  • B7443357722 ()
  • B7443357721 ()
  • B7443357720 ()


  • Autoinjector needle
29G X 1/2" (12mm)
QUALITY MEDICAL PRODUCTS USA, INC.
335771
In Commercial Distribution

  • B7443357713 ()
  • B7443357712 ()
  • B7443357711 ()
  • B7443357710 ()


  • Autoinjector needle
0.3ML 31GX5/16" 1/2 UNIT MARKING
QUALITY MEDICAL PRODUCTS USA, INC.
225945
In Commercial Distribution

  • B7442259453 ()
  • B7442259452 ()
  • B7442259451 ()
  • B7442259450 ()


  • Insulin syringe/needle, basic
1 ML 31GX5/16"
QUALITY MEDICAL PRODUCTS USA, INC.
225944
In Commercial Distribution

  • B7442259443 ()
  • B7442259442 ()
  • B7442259441 ()
  • B7442259440 ()


  • Insulin syringe/needle, basic
1 ML 30GX5/16"
QUALITY MEDICAL PRODUCTS USA, INC.
225943
In Commercial Distribution

  • B7442259433 ()
  • B7442259432 ()
  • B7442259431 ()
  • B7442259430 ()


  • Insulin syringe/needle, basic
1 ML 30GX1/2"
QUALITY MEDICAL PRODUCTS USA, INC.
225942
In Commercial Distribution

  • B7442259423 ()
  • B7442259422 ()
  • B7442259421 ()
  • B7442259420 ()


  • Insulin syringe/needle, basic
1 ML 29GX1/2"
QUALITY MEDICAL PRODUCTS USA, INC.
225941
In Commercial Distribution

  • B7442259413 ()
  • B7442259412 ()
  • B7442259411 ()
  • B7442259410 ()


  • Insulin syringe/needle, basic
0.5 ML 31GX5/16"
QUALITY MEDICAL PRODUCTS USA, INC.
225940
In Commercial Distribution

  • B7442259403 ()
  • B7442259402 ()
  • B7442259401 ()
  • B7442259400 ()


  • Insulin syringe/needle, basic
0.5 ML 30GX5/16"
QUALITY MEDICAL PRODUCTS USA, INC.
225939
In Commercial Distribution

  • B7442259393 ()
  • B7442259392 ()
  • B7442259391 ()
  • B7442259390 ()


  • Insulin syringe/needle, basic
0.5 ML 30GX1/2"
QUALITY MEDICAL PRODUCTS USA, INC.
225938
In Commercial Distribution

  • B7442259383 ()
  • B7442259382 ()
  • B7442259381 ()
  • B7442259380 ()


  • Insulin syringe/needle, basic
0.5 ML 29GX1/2"
QUALITY MEDICAL PRODUCTS USA, INC.
225937
In Commercial Distribution

  • B7442259373 ()
  • B7442259372 ()
  • B7442259371 ()
  • B7442259370 ()


  • Insulin syringe/needle, basic
0.3 ML 31GX5/16"
QUALITY MEDICAL PRODUCTS USA, INC.
225936
In Commercial Distribution

  • B7442259363 ()
  • B7442259362 ()
  • B7442259361 ()
  • B7442259360 ()


  • Insulin syringe/needle, basic
0.3 ML 30GX5/16" 1/2 UNIT MARKING
QUALITY MEDICAL PRODUCTS USA, INC.
225935
In Commercial Distribution

  • B7442259353 ()
  • B7442259352 ()
  • B7442259351 ()
  • B7442259350 ()


  • Insulin syringe/needle, basic
0.3 ML 30GX5/16"
QUALITY MEDICAL PRODUCTS USA, INC.
225934
In Commercial Distribution

  • B7442259343 ()
  • B7442259342 ()
  • B7442259341 ()
  • B7442259340 ()


  • Insulin syringe/needle, basic
0.3 ML 30GX1/2" 1/2 UNIT MARKING
QUALITY MEDICAL PRODUCTS USA, INC.
225933
In Commercial Distribution

  • B7442259333 ()
  • B7442259332 ()
  • B7442259331 ()
  • B7442259330 ()


  • Insulin syringe/needle, basic
0.3 ML 30GX1/2"
QUALITY MEDICAL PRODUCTS USA, INC.
225932
In Commercial Distribution

  • B7442259323 ()
  • B7442259322 ()
  • B7442259321 ()
  • B7442259320 ()


  • Insulin syringe/needle, basic
0.3 ML 29GX1/2"
QUALITY MEDICAL PRODUCTS USA, INC.
225931
In Commercial Distribution

  • B7442259313 ()
  • B7442259312 ()
  • B7442259311 ()
  • B7442259310 ()


  • Insulin syringe/needle, basic
Upper arm blood pressure monitor.
BODYTRACE, INC
BT106
In Commercial Distribution

  • B726BT1061 ()
  • B726BT1060 ()
  • B726BT1062 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Upper arm blood pressure monitor.
BODYTRACE, INC
BT105O
In Commercial Distribution

  • B726BT105O1 ()
  • B726BT105O0 ()
  • B726BT105O2 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
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