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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iCup Dx Pro 2 Integrated CLIA Waived Cup with Adulterants (CR, NI, OX, pH, SG) 5 Panel Drug Screen for AMP1000, COC300, OPI2000, PCP25, THC50
Instant Technologies, Inc.
I-DXP-5A
In Commercial Distribution

  • 00817405021055 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iCup Dx Pro 2 Integrated CLIA Waived Cup with Adulterants (CR,SG,OX) 7 Panel Drug Screen for(AMP/BZO/BUP/COC/OPI300/OXY/THC)
Instant Technologies, Inc.
I-DXP-177-01
In Commercial Distribution

  • 00817405020287 ()
I-DXP-177-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
13 panel test cup, (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+(MTD/TCA)+(OXY/MDMA)+(PCP/AMP1000)+BUP with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMCA-13M
Not in Commercial Distribution

  • 00816565020304 ()
IMCA-13M

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP II 14 Panel Test Cup W/AD, AMP/BARB/BUP/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/PCP/PPX/TCA/THC + PH-CR-OX, 25Pcs/Box
MICRO DISTRIBUTING, L.C
STATâ…¡-13147-0-A
In Commercial Distribution

  • 00816036025159 ()
  • 00816036025319 ()
STATâ…¡-13147-0-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Activelife® Convex One-Piece Pre-Cut Drainable Pouch With Durahesive® Skin Barrier, 12" Trans,W/1 Sided Comfort Panel W/Tape Collar, 2" (50 Mm.)
CONVATEC, PURCHASING DEPARTMENT
175785
In Commercial Distribution

  • 10768455102591 ()
  • 00768455102594 ()
  • 00768455181315 ()


  • One-piece intestinal ostomy bag, open-ended
Activelife® Convex One-Piece Pre-Cut Drainable Pouch With Durahesive® Skin Barrier, 12" Trans,W/1 Sided Comfort Panel W/Tape Collar, 1" (25 Mm.)
CONVATEC, PURCHASING DEPARTMENT
175779
In Commercial Distribution

  • 10768455102539 ()
  • 00768455102532 ()
  • 00768455181254 ()


  • One-piece intestinal ostomy bag, open-ended
12 Panel Drug Screening Test Cup BZO/BAR/COC/THC/MET/OPI300/MTD/OXY/MDMA/AMP/TCA/BUP with Adulteration strip (OX/S.G./CRE/PH)
UCP BIOSCIENCES, INC.
U-DUD-10124-RCN
In Commercial Distribution

  • 20817038020634 ()
  • 10817038020637 ()
  • 00817038020630 ()
U-DUD-10124-RCN

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
13 Panel CLIA Waived Cup - Identify Health AMP500, BAR300, BUP10, BZO300, COC150, MTD300, MDMA500, MET500, OPI300, OXY100, PCP25, TCA1000, THC50 3mm Strip - 25 Pack Box.
MEDICAL DISTRIBUTION GROUP INC
ID-H13-1
Not in Commercial Distribution

  • 01085072100710 ()
  • 00850721007105 ()
ID-H13-1

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
SCHICK ELITE SIZE 0 WITH 9' CABLE ATTACHED
SIRONA DENTAL, INC.
B2403042
In Commercial Distribution

  • D764B24030421 ()


  • Dental digital imaging sensor, intraoral
SCHICK ELITE SIZE 0 WITH 6' CABLE ATTACHED
SIRONA DENTAL, INC.
B2403041
In Commercial Distribution

  • D764B24030411 ()


  • Dental digital imaging sensor, intraoral
SCHICK ELITE SIZE 0 WITH 18" CABLE ATTACHED
SIRONA DENTAL, INC.
B2403040
In Commercial Distribution

  • D764B24030401 ()


  • Dental digital imaging sensor, intraoral
SCHICK ELITE SIZE 2 WITH 3' CABLE ATTACHED
SIRONA DENTAL, INC.
B2402043
In Commercial Distribution

  • D764B24020431 ()


  • Dental digital imaging sensor, intraoral
SCHICK ELITE SIZE 2 WITH 9' CABLE ATTACHED
SIRONA DENTAL, INC.
B2402042
In Commercial Distribution

  • D764B24020421 ()


  • Dental digital imaging sensor, intraoral
SCHICK ELITE SIZE 2 WITH 6' CABLE ATTACHED
SIRONA DENTAL, INC.
B2402041
In Commercial Distribution

  • D764B24020411 ()


  • Dental digital imaging sensor, intraoral
SCHICK ELITE SIZE 2 WITH 18" CABLE ATTACHED
SIRONA DENTAL, INC.
B2402040
In Commercial Distribution

  • D764B24020401 ()


  • Dental digital imaging sensor, intraoral
SCHICK ELITE SIZE 1 WITH 9' CABLE ATTACHED
SIRONA DENTAL, INC.
B2401042
In Commercial Distribution

  • D764B24010421 ()


  • Dental digital imaging sensor, intraoral
SCHICK ELITE SIZE 1 WITH 18" CABLE ATTACHED
SIRONA DENTAL, INC.
B2401040
In Commercial Distribution

  • D764B24010401 ()


  • Dental digital imaging sensor, intraoral
SCHICK ELITE SIZE 0 - 3' REPLACEMENT
SIRONA DENTAL, INC.
B1317053
In Commercial Distribution

  • D764B13170531 ()


  • Dental digital imaging sensor, intraoral
SCHICK ELITE SIZE 0 - 6' REPLACEMENT
SIRONA DENTAL, INC.
B1317051
In Commercial Distribution

  • D764B13170511 ()


  • Dental digital imaging sensor, intraoral
SCHICK ELITE S0 SENSOR SHIP KIT 9 FT
SIRONA DENTAL, INC.
B1317001
In Commercial Distribution

  • D764B13170011 ()


  • Dental digital imaging sensor, intraoral
FONA ELITE SENSOR SIZE 0 KIT
SIRONA DENTAL, INC.
B1311045
In Commercial Distribution

  • D764B13110451 ()


  • Dental digital imaging sensor, intraoral
CDR ELITE SENSOR SHIP KIT S0, 3FT
SIRONA DENTAL, INC.
B1307002
In Commercial Distribution

  • D764B13070021 ()


  • Dental digital imaging sensor, intraoral
CDR ELITE SENSOR SHIP KIT S0, 6FT
SIRONA DENTAL, INC.
B1307000
In Commercial Distribution

  • D764B13070001 ()


  • Dental digital imaging sensor, intraoral
SCHICK ELITE G2 S2 SENSOR
SIRONA DENTAL, INC.
B1217200
In Commercial Distribution

  • D764B12172000 ()


  • Dental digital imaging sensor, intraoral
FONA ELITE REPLACEABLE CABLE KIT 3 FT.
SIRONA DENTAL, INC.
B1211112
In Commercial Distribution

  • D764B12111121 ()


  • Dental digital imaging sensor, intraoral
FONA ELITE REPLACEABLE CABLE KIT 6 FT.
SIRONA DENTAL, INC.
B1211110
In Commercial Distribution

  • D764B12111101 ()


  • Dental digital imaging sensor, intraoral
FONA ELITE SENSOR SIZE 2 KIT
SIRONA DENTAL, INC.
B1211045
In Commercial Distribution

  • D764B12110451 ()


  • Dental digital imaging sensor, intraoral
FONA ELITE SENSOR SIZE 2 SHIP KIT
SIRONA DENTAL, INC.
B1211000
In Commercial Distribution

  • D764B12110001 ()


  • Dental digital imaging sensor, intraoral
SCHICK REPLACEABLE CABLE 3FT
SIRONA DENTAL, INC.
B1209157
In Commercial Distribution

  • D764B12091571 ()


  • Dental digital imaging sensor, intraoral
SCHICK REPLACEABLE CABLE 9FT
SIRONA DENTAL, INC.
B1209156
In Commercial Distribution

  • D764B12091561 ()


  • Dental digital imaging sensor, intraoral
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