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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7 Panel Cup Drug Test, AMP500-COC150-MDMA-MET500-OPI-PCP-THC-pH,SG,OX-CR,NI
Express Diagnostic Int'l, Inc.
60725-5
In Commercial Distribution

  • B29860725510 ()
60725-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 Panel Cup Drug Test, AMP-COC-MDMA-MET500-OPI300-OXY-THC-pH,SG,OX-CR,NI
EXPRESS DIAGNOSTICS INT'L, INC.
60721-5
Not in Commercial Distribution

  • B2986072150 ()
60721-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 Panel Cup Drug Test, AMP-BZO-COC-MET-OPI300-OXY-THC-pH,SG,OX-CR,NI
Express Diagnostic Int'l, Inc.
60711-5
In Commercial Distribution

  • B29860711510 ()
60711-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 Panel Cup Drug Test, AMP-BZO-COC-MET-OPI300-OXY-THC-pH,SG,OX-CR,NI
EXPRESS DIAGNOSTICS INT'L, INC.
60711-5
Not in Commercial Distribution

  • B2986071150 ()
60711-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 Panel Cup Drug Test, AMP-BARB-BZO-COC-OPI-PCP-THC-pH,SG,OX-CR,NI
Express Diagnostic Int'l, Inc.
60708-5
In Commercial Distribution

  • B29860708510 ()
60708-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 Panel Cup Drug Test, AMP-BAR-BZO-COC-OPI-PCP-THC-pH,SG,OX-CR,NI
EXPRESS DIAGNOSTICS INT'L, INC.
60708-5
Not in Commercial Distribution

  • B2986070850 ()
60708-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 Panel Cup Drug Test, COC-MDMA-MET-OPI300-OXY-THC-pH,SG,OX-CR,NI
Express Diagnostic Int'l, Inc.
60699-5
In Commercial Distribution

  • B29860699510 ()
60699-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 Panel Cup Drug Test, COC-MDMA-MET-OPI300-OXY-THC-pH,SG,OX-CR,NI
EXPRESS DIAGNOSTICS INT'L, INC.
60699-5
Not in Commercial Distribution

  • B2986069950 ()
60699-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 Panel Cup Drug Test, AMP-COC-MET500-OPI-PCP-THC-pH,SG,OX-CR,NI
Express Diagnostic Int'l, Inc.
60689-5
In Commercial Distribution

  • B29860689510 ()
60689-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 Panel Cup Drug Test, AMP-COC-MET500-OPI-PCP-THC-pH,SG,OX-CR,NI
EXPRESS DIAGNOSTICS INT'L, INC.
60689-5
Not in Commercial Distribution

  • B2986068950 ()
60689-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel Cup Drug Test, BZO-COC-MET-OPI300-THC-ph,SG,OX-CR,NI
EXPRESS DIAGNOSTICS INT'L, INC.
60536-5
Not in Commercial Distribution

  • B2986053650 ()
60536-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
11 Panel Cup Drug Test, AMP-BARB-BZO-COC-MET-MTD-OPI-OXY-PCP-PPX-THC-pH,SG,OX-CR,NI
Express Diagnostic Int'l, Inc.
51105-DC
In Commercial Distribution

  • B29851105DC10 ()
51105-DC

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Cup Drug Test, AMP-BARB-BZO-COC-MET-MTD-OPI-OXY-PCP-THC-pH,SG,OX-CR,NI
Express Diagnostic Int'l, Inc.
51005-DC
In Commercial Distribution

  • B29851005DC10 ()
51005-DC

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Cup Drug Test, AMP-BARB-BZO-COC-MET-MTD-OPI-OXY-PCP-THC-pH,SG,OX-CR,NI
EXPRESS DIAGNOSTICS INT'L, INC.
51005-DC
In Commercial Distribution

  • B29851005DC0 ()
51005-DC

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Cup Drug Test, AMP-BARB-BZO-COC-MET-MTD-OPI-PCP-THC-pH,SG,OX-CR,NI
EXPRESS DIAGNOSTICS INT'L, INC.
50905-DC
Not in Commercial Distribution

  • B29850905DC0 ()
50905-DC

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 Panel Cup Drug Test, AMP-COC-MET-OPI-OXY-PCP-THC-pH,SG,OX-CR,NI
Express Diagnostic Int'l, Inc.
50715-DC
In Commercial Distribution

  • B29850715DC10 ()
50715-DC

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 Panel Cup Drug Test, BARB-BZO-COC-MET-OPI-PCP-THC-pH,SG,OX-CR,NI
Express Diagnostic Int'l, Inc.
50705-DC
In Commercial Distribution

  • B29850705DC10 ()
50705-DC

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel Cup Drug Test, COC-MET-OPI-PCP-THC-pH,SG,OX-CR,NI
Express Diagnostic Int'l, Inc.
50505-DC
In Commercial Distribution

  • B29850505DC10 ()
50505-DC

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel Dip Drug Test, AMP-BARB-BUP-BZO-COC-MDMA-MET500-MTD-OPI300-OXY-PCP-THC-pH,SG,OX-CR,NI
Express Diagnostic Int'l, Inc.
31234-5
In Commercial Distribution

  • B2983123450 ()
31234-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel Dip Drug Test, AMP-BAR-BUP-BZO-COC-MDMA-MET-MTD-OPI300-OXY-PPX-THC-pH,SG,OX-CR,NI
EXPRESS DIAGNOSTICS INT'L, INC.
31208-5
Not in Commercial Distribution

  • B2983120850 ()
31208-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel Dip Drug Test, AMP-BAR-BZO-COC-MDMA-MET-MTD-OPI300-OXY-PCP-PPX-THC-pH,SG,OX-CR,NI
EXPRESS DIAGNOSTICS INT'L, INC.
31202-5
Not in Commercial Distribution

  • B2983120250 ()
31202-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
11 Panel Dip Drug Test, AMP-BARB-BUP-BZO-COC-MDMA-MET-MTD-OPI300-OXY-THC-pH,SG,OX-CR,NI
Express Diagnostic Int'l, Inc.
31135-5
In Commercial Distribution

  • B29831135510 ()
31135-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Dip Drug Test, AMP-BAR-BZO-COC-MDMA-MTD-OPI-OXY-PCP-THC-pH,SG,OX-CR,NI
EXPRESS DIAGNOSTICS INT'L, INC.
31012-5
Not in Commercial Distribution

  • B2983101250 ()
31012-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Dip Drug Test, AMP-BUP-BZO-COC-MET-MTD-OPI300-OXY-THC-pH,SG,OX-CR,NI
EXPRESS DIAGNOSTICS INT'L, INC.
30970-5
Not in Commercial Distribution

  • B2983097050 ()
30970-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel Dip Drug Test, COC-MDMA-MET-OPI300-THC-pH,SG,OX-CR,NI
EXPRESS DIAGNOSTICS INT'L, INC.
30581-5
Not in Commercial Distribution

  • B2983058150 ()
30581-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel Dip Drug Test, AMP500-COC150-MET500-OPI-THC-pH,SG,OX-CR,NI
Express Diagnostic Int'l, Inc.
30501-5
In Commercial Distribution

  • B29830501510 ()
30501-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel Dip Drug Test, AMP-COC-MET-OPI-THC-pH,SG,OX-CR,NI
Express Diagnostic Int'l, Inc.
30500-5
In Commercial Distribution

  • B29830500510 ()
30500

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel Dip Drug Test, AMP-COC-MET-OPI-THC-pH,SG,OX-CR,NI
EXPRESS DIAGNOSTICS INT'L, INC.
30500-5
Not in Commercial Distribution

  • B2983050050 ()
30500-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
OralTox 6 Panel - COC/MET/OPI/OXY/PCP/THC
PREMIER BIOTECH, INC
OT80622
Not in Commercial Distribution

  • B313OT806221 ()
  • B313OT806220 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 Panel OralTox - AMP/COC/MET/OPI/OXY/THC
PREMIER BIOTECH, INC
OT80605
Not in Commercial Distribution

  • B313OT806051 ()
  • B313OT806050 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 Panel OralTox - AMP/COC/MET/OPI/PCP/THC
PREMIER BIOTECH, INC
OT80602
Not in Commercial Distribution

  • B313OT806021 ()
  • B313OT806020 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel OralTox Device - COC/MET/OPI/OXY/THC
PREMIER BIOTECH, INC
OT80509
Not in Commercial Distribution

  • B313OT805091 ()
  • B313OT805090 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel Preview Cup: AMP1000, COC300, MET1000, MOP300, OXY100
WONDFO USA CO., LTD.
PRE-PDOA-755
In Commercial Distribution

  • 10816862021803 ()
  • 00816862021806 ()
  • 00816862021813 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel DOA Test clear Round Cup With Clicker;
Healgen Scientific Limited Liability Company
HCDOAEC-6125S
In Commercial Distribution

  • 10816490024375 ()
  • 00816490024378 ()
  • 20816490024372 ()
HCDOAEC-6125S

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 Panel DOA Test clear Round Cup With Clicker;
Healgen Scientific Limited Liability Company
HCDOAV-275
In Commercial Distribution

  • 20816490023481 ()
  • 10816490023484 ()
  • 00816490023487 ()
HCDOAV-275

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 panel test cup, BZO/COC/MET1000/OPI300/THC
AMEDITECH INC.
IMC-5MB300
Not in Commercial Distribution

  • 00816565020151 ()
IMC-5MB300

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 panel test cup, AMP/COC/MET1000/OPI2000/THC
AMEDITECH INC.
IMC-5M
Not in Commercial Distribution

  • 00816565020144 ()
IMC-5M

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 panel test cup, BZO300/COC300/MTD300/OPI300/THC50
AMEDITECH INC.
IMC-5BO3
Not in Commercial Distribution

  • 00816565020137 ()
IMC-5BO3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
OEC Elite MiniView C-Arm Drape – 13 cm Flat Panel
EXACT MEDICAL MANUFACTURING, INC.
E6066
In Commercial Distribution

  • 26975424196210 ()
  • 06975424196216 ()
E6066

  • Medical equipment/instrument drape, single-use
Sample Collection Kit, Blood (Adx Dual), Women's Fertility Panel
Cue Health Inc.
C2227
In Commercial Distribution

  • 00810040821066 ()


  • Capillary blood collection kit IVD
Sample Collection Kit, Blood (5 DBS), Food Sensitivity Panel
Cue Health Inc.
C2234
In Commercial Distribution

  • 00810040821103 ()


  • Capillary blood collection kit IVD
Sample Collection Kit, Blood (Adx Dual), Women's Health Panel
Cue Health Inc.
C2226
In Commercial Distribution

  • 00810040821059 ()


  • Capillary blood collection kit IVD
Sample Collection Kit, Blood (Adx Single), Men's Health Panel
Cue Health Inc.
C2245
In Commercial Distribution

  • 00810040821011 ()


  • Capillary blood collection kit IVD
Sample Collection Kit, Blood (Adx Single), Heart Health Panel
Cue Health Inc.
C2224
In Commercial Distribution

  • 00810040820984 ()


  • Capillary blood collection kit IVD
FIXED ARM SIDEFRAME & SIDE PANEL - LEFT - TRAVELER SE PLUS
GF HEALTH PRODUCTS, INC.
90763002A
In Commercial Distribution

  • M36890763002A1 ()
90763002A

  • Push-rim manual wheelchair, non-bariatric
FIXED ARM SIDEFRAME & SIDE PANEL - RIGHT - TRAVELER SE PLUS
GF HEALTH PRODUCTS, INC.
90763001A
In Commercial Distribution

  • M36890763001A1 ()
90763001A

  • Push-rim manual wheelchair, non-bariatric
The DR-ID 1836SE incorporate a GOS indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph.
FUJIFILM CORPORATION
DR-ID 1836 SE E
In Commercial Distribution

  • 04547410483420 ()

  • 460x850x15mm


  • Stationary basic diagnostic x-ray system, digital
POS and NEG external qc to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of pathogens included in BIOFIRE SPOTFIRE R Panel, BIOFIRE SPOTFIRE R Panel Mini, BIOFIRE SPOTFIRE R/ST Panel and BIOFIRE SPOTFIRE R/ST Panel Mini
Mmqci
v.00
In Commercial Distribution

  • 00852720008145 ()
M425

  • Multiple-genus respiratory virus nucleic acid IVD, control
SureSmile Dr Starter Kit
DENTSPLY SIRONA ORTHODONTICS INC.
ORX00001
Not in Commercial Distribution

  • D746ORX000010 ()
  • D746ORX000011 ()
ORX00001

  • Dental abrasive strip, reusable
  • Dental delivery system instrument unit, pneumatic
The Single Flat Panel Monitor, Light Head with Video, Single Flat Panel Monitor-G Series is used with the HarmonyAIR G-Series Suspension System.
STERIS CORPORATION
G-Series Suspension
Not in Commercial Distribution

  • 00724995166731 ()
LGH00037

  • Medical monitor/light mount
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