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, CLASSIC CROWN, 2.00MM, 145CM SHAFT
Cardiovascular Systems, Inc.
DBP-200CLASS145
In Commercial Distribution

  • 10850000491257 ()

  • Intro Sheath: 6 Fr
  • Max OD: 0.079 inches
  • Crown Type: Classic
  • high speed: 140 krpm
  • medium speed: 90 krpm
  • low speed: 60 krpm
  • guidewire size OD: 0.014 inches
  • shaft length: 145 cm
  • nose length: 20 mm
  • Crown diameter: 2.00 mm
7-10057-09

  • Mechanical atherectomy system catheter, peripheral
DIAMONDBACK PERIPHERAL, CLASSIC CROWN, 1.50MM, 145CM SHAFT
Cardiovascular Systems, Inc.
DBP-150CLASS145
In Commercial Distribution

  • 10850000491240 ()

  • Intro Sheath: 5 Fr
  • Max OD: 0.063 inches
  • Crown Type: Classic
  • high speed: 140 krpm
  • medium speed: 90 krpm
  • low speed: 60 krpm
  • guidewire size OD: 0.014 inches
  • shaft length: 145 cm
  • nose length: 15 mm
  • Crown diameter: 1.50 mm
7-10057-08

  • Mechanical atherectomy system catheter, peripheral
Diamondback Peripheral, Solid Crown, 1.75MM, 180CM shaft
Cardiovascular Systems, Inc.
DBP-175SOLID180
In Commercial Distribution

  • 10850000491233 ()

  • Intro Sheath: 5 Fr
  • Max OD: 0.069 inches
  • Crown Type: Solid
  • high speed: 120 krpm
  • medium speed: 90 krpm
  • low speed: 60 krpm
  • Guidewire: 0.014 inches
  • shaft length: 180 cm
  • nose length: 30 mm
  • Crown diameter: 1.75 mm
7-10057-07

  • Mechanical atherectomy system catheter, peripheral
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
0.014" Shepherd ES Guidewire - straight 195 cm - 4 gms
Cardiovascular Systems, Inc.
PSP14S-19504
In Commercial Distribution

  • 30850026568531 ()
  • 10850026568537 ()

  • Guidewire Diameter: 0.014 Inch
  • Length: 195 Inch
  • Hydrophilic Coating
  • Tip Flex 4 Grams
  • Tip Shape Straight
  • Tip Design Polymer Jacket
7-10096-01

  • Peripheral vascular guidewire, manual
Pointe Cannabinoids (THC) Control (125 ng/mL) 1 x 5 mL 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-TH0018-5
In Commercial Distribution

  • 00811727017383 ()
60-TH0018-5

  • Cannabinoid/cannabinoid metabolite IVD, control
Pointe Cannabinoids (THC) Control (62.5 ng/mL) 1 x 5 mL 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-TH0016-5
In Commercial Distribution

  • 00811727017352 ()
60-TH0016-5

  • Cannabinoid/cannabinoid metabolite IVD, control
Pointe Cannabinoids (THC) Control (31.25 ng/mL) 1 x 5 mL 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-TH0148-5
In Commercial Distribution

  • 00811727017321 ()
60-TH0148-5

  • Cannabinoid/cannabinoid metabolite IVD, control
Pointe Cannabinoids (THC) Control (18.75 ng/mL) 1 x 5 mL 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-TH0012-5
In Commercial Distribution

  • 00811727017314 ()
60-TH0012-5

  • Cannabinoid/cannabinoid metabolite IVD, control
Pointe Cannabinoids (THC) Calibrator/Control (37.5 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.
POINTE SCIENTIFIC, INC.
60-TH0014-5
In Commercial Distribution

  • 00811727017291 ()
60-TH0014-5

  • Cannabinoid/cannabinoid metabolite IVD, calibrator
Pointe Cannabinoids (THC) Negative Calibrator (0 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.
POINTE SCIENTIFIC, INC.
60-TH0004-5
In Commercial Distribution

  • 00811727017260 ()
60-TH0004-5

  • Cannabinoid/cannabinoid metabolite IVD, calibrator
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
Qtest 5 (25 pack) - AMP 1000, COC 300, MET 1000, OPI 2000,THC 50
MEDIMPEX UNITED, INC
QT-CUP
In Commercial Distribution

  • 10864040000317 ()


  • Drug/toxicology screen adulteration IVD, kit, rapid spectrophotometry, clinical
PANEL 12 COC/AMP/M-AMP/THC/MTD/MDMA/ OPI/OXY/PPX/PCP/BAR/BZO
REDWOOD TOXICOLOGY LABORATORY, INC.
011020141
In Commercial Distribution

  • 10858904006461 ()
  • 00858904006464 ()
DOA-1124-051

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 11 COC/THC/OPI300/AMP/MAMP/BAR/BZO/MTD/OXY/P CP/BUP
REDWOOD TOXICOLOGY LABORATORY, INC.
011020184
In Commercial Distribution

  • 10858904006416 ()
  • 00858904006419 ()
DOA-1114-101

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 11 COC/THC/OPI300/AMP/MAMP/BAR/BZO/MTD/OXY/P CP/BUP
REDWOOD TOXICOLOGY LABORATORY, INC.
011020183
In Commercial Distribution

  • 10858904006409 ()
  • 00858904006402 ()
DOA-1104-751

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Instant-View Multi-Drug of Abuse Urine Cup Test AMP COC MET MOR/OPI PCP THC
ALFA SCIENTIFIC DESIGNS, INC.
03-4438
In Commercial Distribution

  • 10796918002102 ()
  • 00796918002105 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Multi-Drug of Abuse Urine Cup Test AMP COC MET MOR/OPI OXY PCP THC
ALFA SCIENTIFIC DESIGNS, INC.
03-4433
In Commercial Distribution

  • 10796918001860 ()
  • 00796918001863 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
INSTANT-VIEW Multi-Drugs of Abuse Dip Test AMP, BAR, BZD, COC, MOR300 MTD, OXY, THC
ALFA SCIENTIFIC DESIGNS, INC.
03-6851QW
In Commercial Distribution

  • 10796918001723 ()
  • 00796918001726 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
INSTANT-VIEW Multi-Drug of Abuse Urine Cup Test AMP BZD COC MET MOR MTD THC
ALFA SCIENTIFIC DESIGNS, INC.
03-4431
In Commercial Distribution

  • 10796918001501 ()
  • 00796918001504 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
INSTANT-VIEW Multi-Drug of Abuse Urine Cup Test AMP BZD COC MET MOR PCP THC
ALFA SCIENTIFIC DESIGNS, INC.
03-4430
In Commercial Distribution

  • 10796918001495 ()
  • 00796918001498 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BZD, COC, MET1000, MOR2000, PCP, THC
ALFA SCIENTIFIC DESIGNS, INC.
03-3855
In Commercial Distribution

  • 10796918001280 ()
  • 00796918001283 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
ACCUTEST Multi-Drug Screen 6-Panel Cassette Format *CLIA Waived* (AMP, COC, THC, MAMP, OPI, PCP)
JANT PHARMACAL CORPORATION
DS56
In Commercial Distribution

  • 10763924056429 ()
  • 00763924056422 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
ACCUTEST Multi-Drug Screen NIDA 5-Panel Cassette Format *CLIA Waived* (AMP, COC, THC, OPI, PCP)
JANT PHARMACAL CORPORATION
DS55
In Commercial Distribution

  • 10763924055422 ()
  • 00763924055425 ()


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

  • 00817405020652 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Prime Screen® 6-Panel Card; 10 per box; AMP,BZO,COC,MET,OPI,THC
WONDFO USA CO., LTD.
DWDOA-264-10BX-A
In Commercial Distribution

  • 10816862026310 ()
  • 00816862026313 ()
  • 00816862026306 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel Card; AMP,BAR,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,TCA,THC
WONDFO USA CO., LTD.
WDOA-7125
In Commercial Distribution

  • 00816862025736 ()
WDOA-7125

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel Card; AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,THC
WONDFO USA CO., LTD.
WDOA-6125
In Commercial Distribution

  • 00816862025699 ()
WDOA-6125

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