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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Diamondback Peripheral, Solid Crown, 1.50MM, 200CM shaft
Cardiovascular Systems, Inc.
DBP-150SOLID200
In Commercial Distribution

  • 10850000491226 ()

  • Intro Sheath: 5 Fr
  • Max OD: 0.063 inches
  • Crown Type: Solid
  • high speed: 120 krpm
  • medium speed: 90 krpm
  • low speed: 60 krpm
  • Guidewire: 0.014 inches
  • shaft length: 200 cm
  • nose length: 10 mm
  • Crown diameter: 1.50 mm
7-10057-06

  • Mechanical atherectomy system catheter, peripheral
Diamondback Peripheral, Solid Crown, 1.25MM, 200CM shaft
Cardiovascular Systems, Inc.
DBP-125SOLID200
In Commercial Distribution

  • 10850000491219 ()

  • Intro Sheath: 5 Fr
  • Max OD: 0.063 inches
  • Crown Type: Solid
  • high speed: 120 krpm
  • medium speed: 90 krpm
  • low speed: 60 krpm
  • Guidewire: 0.014 inches
  • shaft length: 200 cm
  • nose length: 10 mm
  • Crown diameter: 1.25 mm
7-10057-05

  • Mechanical atherectomy system catheter, peripheral
DIAMONDBACK PERIPHERAL, SOLID CROWN, 2.00MM, 145CM SHAFT
Cardiovascular Systems, Inc.
DBP-200SOLID145
In Commercial Distribution

  • 10850000491202 ()

  • Intro Sheath: 6 Fr
  • Max OD: 0.079 inches
  • Crown Type: Solid
  • high speed: 120 krpm
  • medium speed: 90 krpm
  • low speed: 60 krpm
  • Guidewire: 0.014 inches
  • shaft length: 145 cm
  • nose length: 30 mm
  • Crown diameter: 2.00 mm
7-10057-04

  • Mechanical atherectomy system catheter, peripheral
DIAMONDBACK PERIPHERAL, SOLID CROWN, 1.50MM, 145CM SHAFT
Cardiovascular Systems, Inc.
DBP-150SOLID145
In Commercial Distribution

  • 10850000491196 ()

  • Intro Sheath: 5 Fr
  • Max OD: 0.063 inches
  • Crown Type: Solid
  • high speed: 120 krpm
  • medium speed: 90 krpm
  • low speed: 60 krpm
  • guidewire size: OD 0.014 inches
  • shaft length: 145 cm
  • nose length: 10 mm
  • Crown diameter: 1.50 mm
7-10057-03

  • Mechanical atherectomy system catheter, peripheral
DIAMONDBACK PERIPHERAL, SOLID CROWN, 1.25MM, 145CM SHAFT
Cardiovascular Systems, Inc.
DBP-125SOLID145
In Commercial Distribution

  • 10850000491189 ()

  • Intro Sheath: 4 Fr
  • Max OD: 0.052 inches
  • Crown Type: Solid
  • high speed: 120 krpm
  • medium speed: 90 krpm
  • low speed: 60 krpm
  • guidewire size OD: 0.014 inches
  • shaft length: 145 cm
  • nose length: 7 mm
  • Crown diameter: 1.25 mm
7-10057-02

  • Mechanical atherectomy system catheter, peripheral
DIAMONDBACK PERIPHERAL, MICRO CROWN, 1.25MM, 145CM SHAFT
Cardiovascular Systems, Inc.
DBP-125MICRO145
In Commercial Distribution

  • 10850000491172 ()

  • Intro Sheath: 4 Fr
  • Max OD: 0.052 inches
  • Crown type: Micro
  • high speed: 140 krpm
  • medium speed: 90 krpm
  • low speed: 60 krpm
  • Guidewire: 0.014 inches
  • shaft length: 145 cm
  • nose length: 7 mm
  • Crown diameter: 1.25 mm
7-10057-01

  • Mechanical atherectomy system catheter, peripheral
Diamondback Peripheral, Exchangeable Series, Handle Only
Cardiovascular Systems, Inc.
DBP-EX-HANDLE
In Commercial Distribution

  • 10850000491035 ()
7-10032-01

  • Mechanical atherectomy system catheter, peripheral
Diamondback Peripheral, Exchangeable Series, Cartridge, 2.00 Classic, 145 cm shaft
Cardiovascular Systems, Inc.
DBP-CART-200CLA145
In Commercial Distribution

  • 10850000491028 ()

  • Intro Sheath: 6 Fr
  • Max OD: 0.079 inches
  • Crown Type: Classic
  • High Speed: 140krpm
  • Medium Speed: 90krpm
  • Low Speed: 60krpm
  • Guidewire: 0.014 inches
  • Shaft Length: 145cm
  • Nose Length: 20mm
  • Crown Diameter: 2.00mm
7-10031-11

  • Mechanical atherectomy system catheter, peripheral
Diamondback Peripheral, Exchangeable Series, Cartridge, 1.50 Clasic, 145 cm shaft
Cardiovascular Systems, Inc.
DBP-CART-150CLA145
In Commercial Distribution

  • 10850000491011 ()

  • Intro Sheath: 5 Fr
  • Max OD: 0.063 inches
  • Crown Type: Classic
  • High Speed: 140krpm
  • Medium Speed: 90krpm
  • Low Speed: 60krpm
  • Guidewire: 0.014 inches
  • Shaft Length: 145cm
  • Nose Length: 15mm
  • Crown Diameter: 1.50mm
7-10031-10

  • Mechanical atherectomy system catheter, peripheral
DIAMONDBACK CORONARY, CLASSIC CROWN, 1.25MM, 135CM SHAFT
Cardiovascular Systems, Inc.
DBEC-125
In Commercial Distribution

  • 10850026568698 ()

  • Low Speed 80krpm
  • Medium Speed krpm
  • High Speed 120krpm
  • Crown Type Classic
  • Max OD 0.0495in
  • Intro Sheath 6Fr
  • Crown Diameter 1.25mm
  • Nose Length 5mm
  • Shaft Length: 135 Centimeter
  • Guidewire Size OD 0.012in
7-10098-01

  • Mechanical atherectomy system, coronary, line-powered
Rapid Response Multi Drug Test Panel (COC/AMP/MET/THC/OPI/MDMA) - 25 tests/ kit are for qualitative detection of Amphetamine, Methamphetamine, Opiates, 3,4-Methyoxydiene-Methamphetamine, Cocaine and THC metabolites in urine.
BTNX Inc
D6.14-1P29-25
In Commercial Distribution

  • 00722066003459 ()
  • 00722066004012 ()
D6.14-1P29-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response Multi Drug Test Panels (COC/AMP/MET/THC/OPI/BZO) - 25 tests/ kit are for qualitative detection of Amphetamine, Methamphetamine, Opiates, Benzodiazepines, THC and Cocaine metabolites in urine.
BTNX Inc
D6.1-1P29-25
In Commercial Distribution

  • 00722066000830 ()
  • 00722066004005 ()
D6.1-1P29-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Pointe Cannabinoids (THC) Calibrator Control (75 ng/mL) 1 x 5 mL The Pointe Cannabinoids (THC) Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the Pointe Cannabinoids (THC) Reagent Set (Ref# 60-CA0140-100/60-CA0140-1L) on a number of automated clinical chemistry analyzers. The Pointe Cannabinoids (THC) Controls are for use as assayed quality control materials to monitor the precision of the Pointe Cannabinoids (THC) Reagent Set (Ref# 60-CA0140-100/60-CA0140-1L) on a number of automated clinical chemistry analyzers.
POINTE SCIENTIFIC, INC.
60-TH0152-5
In Commercial Distribution

  • 00811727017338 ()
60-TH0152-5

  • Cannabinoid/cannabinoid metabolite IVD, calibrator
Rapid Response Multi Drug Integrated Split Specimen Cup (COC/MET/THC/OPI/PCP) - 25 tests/ kit are for the qualitative detection of Methamphetamine, Opiates, Phencyclidine, Cocaine and THC metabolites in urine.
BTNX Inc
D5.3-1G29-25
In Commercial Distribution

  • 00722066000885 ()
  • 00722066004104 ()
D5.3-1G29-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
TOX/See Drug Screen Test AMP, BAR, BZO, COC, MET, OPI, PCP, TCA, THC
BIO-RAD LABORATORIES, INC.
194-5230
In Commercial Distribution

  • 00847817000393 ()
1945230

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
1 Panel urine cup that tests for THC (Marijuana) which includes a Lab Confirmation.
ALLSOURCE SCREENING SOLUTIONS, LLC
ALLTHCR
In Commercial Distribution

  • 00861272000392 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
1 Panel urine cup that tests for THC (Marijuana) which includes a Lab Confirmation.
ALLSOURCE SCREENING SOLUTIONS, LLC
ALLTHCR
In Commercial Distribution

  • 00861272000361 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
1 Panel urine cup that tests for THC (Marijuana) which includes a Lab Confirmation.
ALLSOURCE SCREENING SOLUTIONS, LLC
ALLTHCR
In Commercial Distribution

  • 00861272000309 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC/COC/OPI/AMP/MET/BZO/MTD/OXY/BUP drugs of abuse test cup
Twin Spirit Inc.
60960D
Not in Commercial Distribution

  • 00859144006153 ()
60960D

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Cup, (COC/THC)+(MET1000/OPI2000)+(PCP/AMP)+BAR+BZO+MDMA+MTD
Instant Tech Subsidiary Acquisition
PSCup-10CT
Not in Commercial Distribution

  • 00858998006975 ()
PSCup-10CT

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Card, (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+(PCP/AMP)+MTD
Instant Tech Subsidiary Acquisition
PSD-9P
Not in Commercial Distribution

  • 00858998006920 ()
PSD-9P

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Cup, (COC/THC)+(MET1000/OPI2000)+(OXY/MDMA)+AMP+BAR+BZO+BUP
Instant Tech Subsidiary Acquisition
PSCup-10BUP
Not in Commercial Distribution

  • 00858998006760 ()
PSCup-10BUP

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Card, (COC/THC)+(MET1000/OPI2000)+(PCP/AMP)+BAR+BZO+MTD
Instant Tech Subsidiary Acquisition
PSD-9CT
Not in Commercial Distribution

  • 00858998006623 ()
PSD-9CT

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Cup, (BAR/BZO)+(COC/THC)+(OXY/MDMA)+AMP+MET1000+MTD+OPI300
Instant Tech Subsidiary Acquisition
PSCup-10MMO300
Not in Commercial Distribution

  • 00858998006562 ()
PSCup-10MMO300

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Cup, (BZO/BAR)+(MET1000/OPI2000)+(PCP/AMP)+COC+MDMA+MTD+THC
Instant Tech Subsidiary Acquisition
PSCup-10M
Not in Commercial Distribution

  • 00858998006555 ()
PSCup-10M

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Cup, (BZO/BAR)+(COC/THC)+(MET/OPI)+(OXY/MDMA)+AMP+BUP
Instant Tech Subsidiary Acquisition
PSCup-10AB
Not in Commercial Distribution

  • 00858998006548 ()
PSCup-10AB

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Cup, CLIA Waived, (MET1000/OPI2000)+AMP+BAR+BZO+COC+PCP+THC
Instant Tech Subsidiary Acquisition
PSCup-8P-W
Not in Commercial Distribution

  • 00858998006531 ()
PSCup-8P-W

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
U-Screen Squared Integrated Cup 5 Panel Drug Screen for (THC/COC/OPI2000/MET/BZO)
Instant Tech Subsidiary Acquisition
USSCup-5MB
Not in Commercial Distribution

  • 00858998006043 ()
USSCup-5MB

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC, COC, OPI, AMP, MET, PCP, BZO, BAR, MTD drugs of abuse test cup
NEXSCREEN, LLC
60925N
Not in Commercial Distribution

  • 00858984006033 ()
60925N

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Areta 5 Panel Drug Test Cup (50 Test Kit) - THC,COC,OPI2000,BZO,AMP
EASY HEALTHCARE CORPORATION
ACDOA-754
In Commercial Distribution

  • 00855944007543 ()
  • 30855944007544 ()
ACDOA-754-50

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Areta 5 Panel Drug Test Cup (25 Test Kit) - THC,COC,OPI2000,BZO,AMP
EASY HEALTHCARE CORPORATION
ACDOA-754
In Commercial Distribution

  • 10855944007274 ()
  • 00855944007277 ()
  • 30855944007278 ()
ACDOA-754-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Areta 5 Panel Drug Test Cup (5 Test Kit) - THC,COC,OPI2000,BZO,AMP
EASY HEALTHCARE CORPORATION
ACDOA-754
In Commercial Distribution

  • 00855944007260 ()
  • 30855944007261 ()
  • 10855944007267 ()
ACDOA-754-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Areta 5 Panel Drug Test Cup (100 Test Kit) - THC,COC,OPI2000,BZO,AMP
EASY HEALTHCARE CORPORATION
ACDOA-754
In Commercial Distribution

  • 00855944007550 ()
  • 30855944007551 ()
ACDOA-754-100

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Areta 5 Panel Drug Test Cup (10 Test Kit) - THC,COC,OPI2000,BZO,AMP
EASY HEALTHCARE CORPORATION
ACDOA-754
In Commercial Distribution

  • 00855944007536 ()
  • 30855944007537 ()
ACDOA-754-10

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Five Panel PreScreen Plus Cup (CLIA Waived) Drug Combo: AMP | COC | OPI | PCP | THC
MERGERS MARKETING, INC.
PSC-DOA-154
In Commercial Distribution

  • 10851000007141 ()
  • 00851000007144 ()
  • 00851000007137 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Five Panel Clear Scan Drug Test Cup Drug Combo: BZO | COC | MET | MOR | THC
MERGERS MARKETING, INC.
CSC-654
In Commercial Distribution

  • 10850557007871 ()
  • 00850557007874 ()
  • 00850557007867 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Five Panel Clear Scan Drug Test Cup Drug Combo: AMP | COC | MET | OPI | THC
MERGERS MARKETING, INC.
CSC-254
In Commercial Distribution

  • 10850557007833 ()
  • 00850557007836 ()
  • 00850557007829 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Five Panel PreScreen Plus Cup (CLIA Waived) Drug Combo: BZO | COC | MET | MOR | THC
MERGERS MARKETING, INC.
PSC-DOA-654
In Commercial Distribution

  • 00850557007546 ()
  • 10850557007550 ()
  • 00850557007553 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Five Panel PreScreen Plus Cup (CLIA Waived) Drug Combo: AMP | COC | MET | OPI | THC
MERGERS MARKETING, INC.
PSC-DOA-254
In Commercial Distribution

  • 00850557007423 ()
  • 00850557007430 ()
  • 10850557007437 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9-Panel DOA Cup, AMP/BZO/COC/MET/MTD/MOR300/OXY/PCP/THC, 25tests/kit
CHEMTRON BIOTECH INC
712I01
In Commercial Distribution

  • 00850019007916 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9-Panel DOA Cup, AMP/BAR/BZO/COC/MET/MTD/OPI2000/PCP/THC, 25tests/kit
CHEMTRON BIOTECH INC
KCUR920077
In Commercial Distribution

  • 00850019007886 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DrugSmart Cup 8, AMP/OPI2K/THC/COC/MET/BZO/MTD/OXY, CLIA-Waived, 25tests/kit
CHEMTRON BIOTECH INC
C-60820D
In Commercial Distribution

  • 00850019007794 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DrugSmart Cup 9, AMP/BAR/BZO/COC/MTD/OPI2K/PCP/PPX/THC, 25tests/kit
CHEMTRON BIOTECH INC
60980D
In Commercial Distribution

  • 00850019007589 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Chemtrue® 6-Panel DOA Cup Test, THC/MOR300/BZO/MET/AMP/COC, 25pcs/kit
CHEMTRON BIOTECH INC
CTDOA167072
In Commercial Distribution

  • 00850019007527 ()
CTDOA167072

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Chemtrue® 6-Panel DOA Cup Test, AMP/COC/MET/MOR300/OXY/THC, 25pcs/kit
CHEMTRON BIOTECH INC
CCDOA266
In Commercial Distribution

  • 00850019007510 ()
CCDOA266

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DrugSmart Cup 9, THC/COC/MOR300/AMP/MET/BZO/MTD/BUP/OXY, 25pcs/kit
CHEMTRON BIOTECH INC
C60963D
In Commercial Distribution

  • 00850019007497 ()
C60963D

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6-Panel Drug Screen Dip Card Tests, AMP/BZO/COC/MET/MOR300/THC, 25pcs/kit
CHEMTRON BIOTECH INC
711F01
In Commercial Distribution

  • 00850019007343 ()
711F01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
8-Panel DOA Cup, BUP/BZO/COC/MET/MTD/MOR/OXY/THC, 25 tests/kit
CHEMTRON BIOTECH INC
712H01D
In Commercial Distribution

  • 00850019007985 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA WAIVED (THC/COC/OPI300/AMP/MET/PCP/BZO/BAR/MDMA/MTD/OXY/BUP)
Medical Disposables Corp
ODTC-6125
In Commercial Distribution

  • 00850041101798 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA WAIVED (THC/COC/OPI300/AMP/MET/PCP/BZO/BAR/MDMA/MTD/OXY/BUP)
Medical Disposables Corp
ODTC-6125
In Commercial Distribution

  • 00850041101781 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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