SEARCH RESULTS FOR: hibcc(669058 results)

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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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Bur PM2-70 80K steel Ø1.8mm sterile - J00711003550011

No Description
Bien-Air Surgery SA
1100355
Not in Commercial Distribution

  • J00711003550051 ()
  • J00711003550011 ()
1100355-001

  • Metal/carbide ENT bur, single-use

Bur PM2-70 80K steel Ø1.4mm sterile - J00711003540011

No Description
Bien-Air Surgery SA
1100354
Not in Commercial Distribution

  • J00711003540051 ()
  • J00711003540011 ()
1100354-001

  • Metal/carbide ENT bur, single-use

Bur PM2-70 80K steel Ø1.0mm sterile - J00711003530011

No Description
Bien-Air Surgery SA
1100353
Not in Commercial Distribution

  • J00711003530051 ()
  • J00711003530011 ()
1100353-001

  • Metal/carbide ENT bur, single-use

Bur PM2-70 80K steel Ø0.8mm sterile - J00711003520011

No Description
Bien-Air Surgery SA
1100352
Not in Commercial Distribution

  • J00711003520051 ()
  • J00711003520011 ()
1100352-005

  • Metal/carbide ENT bur, single-use

Bur PM2-70 80K steel Ø0.6mm sterile - J00711003510011

No Description
Bien-Air Surgery SA
1100351
Not in Commercial Distribution

  • J00711003510051 ()
  • J00711003510011 ()
1100351-001

  • Metal/carbide ENT bur, single-use

Coeur Nemoto - M902554080

200mL/200mL CT Dual Syringe Pack Includes (1) Y-set /(1) Check Valve / (2) Spikes
COEUR, INC.
C855-5408
In Commercial Distribution

  • M902554086 ()
  • M902554080 ()

  • Total Volume: 200 Milliliter
C855-5408

  • Angiographic syringe

Coeur Nemoto - M902554040

Nemoto 200ml/200mL Dual Pack w/ fill tube
COEUR, INC.
C855-5404
In Commercial Distribution

  • M902554046 ()
  • M902554040 ()

  • Total Volume: 200 Milliliter
C855-5404

  • Angiographic syringe

Coeur Nemoto - M902553080

200mL /100mL Disposable CT Dual Syringe Pack includes (1) Y-Set / (1) Check Valve / (2) Spikes
COEUR, INC.
C855-5308
In Commercial Distribution

  • M902553086 ()
  • M902553080 ()

  • Total Volume: 100 Milliliter
  • Total Volume: 200 Milliliter
C855-5308

  • Angiographic syringe

Coeur Nemoto - M902553040

Nemoto 100ml/200mL Dual Pack w/ fill tube
COEUR, INC.
C855-5304
In Commercial Distribution

  • M902553046 ()
  • M902553040 ()

  • Total Volume: 200 Milliliter
  • Total Volume: 100 Microliter
C855-5304

  • Angiographic syringe

Coeur Nemoto - M902552580

200mL /50mL Disposable CT Dual Syringe Pack includes (1) Y-Set / (1) Check Valve / (2) Spikes
COEUR, INC.
C855-5258
In Commercial Distribution

  • M902552586 ()
  • M902552580 ()

  • Total Volume: 50 Milliliter
  • Total Volume: 200 Milliliter
C855-5258

  • Angiographic syringe

Coeur Nemoto - M902552060

200mL Disposable CT Syringe Includes (1) 60” Coiled Extension Line / (1) Fill Spike
COEUR, INC.
C855-5206
In Commercial Distribution

  • M902552066 ()
  • M902552060 ()

  • Total Volume: 200 Milliliter
C855-5206

  • Angiographic syringe

Coeur Nemoto - M902552020

Nemoto 200ml w/ coiled line and fill tube
COEUR, INC.
C855-5202
In Commercial Distribution

  • M902552026 ()
  • M902552020 ()

  • Total Volume: 200 Milliliter
C855-5202

  • Angiographic syringe

Coeur Nemoto - M902552010

200mL Disposable CT Syringe Includes (1) Fill Tube
COEUR, INC.
C855-5201
In Commercial Distribution

  • M902552016 ()
  • M902552010 ()

  • Total Volume: 200 Milliliter
C855-5201

  • Angiographic syringe

QuickProfile™ HCG Test Card - M901W1C0

immunochromatographic test (IVD) for Human chorionic gonadotropin beta-subunit (beta-HCG)
LUMIQUICK DIAGNOSTICS, INC.
W1-C
In Commercial Distribution

  • M901W1C0 ()
  • M901W1C1 ()

  • Length: 80 Millimeter
W1-C

  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid

QuickProfile™ Drugs of Abuse Test Cup - M90107RD7205020

Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / M-AMP / OPI / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7205-02
In Commercial Distribution

  • M90107RD7205021 ()
  • M90107RD7205020 ()

  • Length: 74 Millimeter
07RD7205-02

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

QuickProfile™ Drugs of Abuse Panel 10 Test - M90107RD7073010

Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BUP / BZD / COC / M-AMP / MTD / OPI / PCP / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7073-01
In Commercial Distribution

  • M90107RD7073011 ()
  • M90107RD7073010 ()

  • Length: 75 Millimeter
07RD7073-01

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

QuickProfile™ Drugs of Abuse Panel 9 Test - M90107RD7072100

Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BUP / BZD / COC / M-AMP / MTD / OPI / OXY / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7072-10
In Commercial Distribution

  • M90107RD7072101 ()
  • M90107RD7072100 ()

  • Length: 75 Millimeter
07RD7072-10

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

QuickProfile™ Drugs of Abuse Panel 7 Test - M90107RD7070170

Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / M-AMP / MTD / OPI / OXY / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7070-17
In Commercial Distribution

  • M90107RD7070171 ()
  • M90107RD7070170 ()

  • Length: 75 Millimeter
07RD7070-17

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

QuickProfile™ Drugs of Abuse Panel 7 Test - M90107RD7070150

Immunoassay for the detection of the following drug substance(s) in human urine: BUP / BZD / COC / M-AMP / OPI / OXY / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7070-15
In Commercial Distribution

  • M90107RD7070151 ()
  • M90107RD7070150 ()

  • Length: 75 Millimeter
07RD7070-15

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

QuickProfile™ Drugs of Abuse Panel 7 Test - M90107RD7070140

Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BUP / BZD / COC / OPI / OXY / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7070-14
In Commercial Distribution

  • M90107RD7070141 ()
  • M90107RD7070140 ()

  • Length: 75 Millimeter
07RD7070-14

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

QuickProfile™ Drugs of Abuse Panel 7 Test - M90107RD7070130

Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD / COC / M-AMP / OPI / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7070-13
In Commercial Distribution

  • M90107RD7070131 ()
  • M90107RD7070130 ()

  • Length: 75 Millimeter
07RD7070-13

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

QuickProfile™ Drugs of Abuse Panel 7 Test - M90107RD7070120

Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BUP / BZD / COC / OPI / OXY / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7070-12
In Commercial Distribution

  • M90107RD7070121 ()
  • M90107RD7070120 ()

  • Length: 75 Millimeter
07RD7070-12

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

QuickProfile™ Drugs of Abuse Panel 7 Test - M90107RD7070040

Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BUP / BZD / COC / MTD / OPI / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7070-04
In Commercial Distribution

  • M90107RD7070041 ()
  • M90107RD7070040 ()

  • Length: 75 Millimeter
07RD7070-04

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

QuickProfile™ Drugs of Abuse Panel 6 Test - M90107RD7065420

Immunoassay for the detection of the following drug substance(s) in human urine: AMP/ BZD / M-AMP / OPI / OXY / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7065-42
In Commercial Distribution

  • M90107RD7065421 ()
  • M90107RD7065420 ()

  • Length: 75 Millimeter
07RD7065-42

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

QuickProfile™ Drugs of Abuse Panel 6 Test - M90107RD7065320

Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / M-AMP / OPI / PCP / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7065-32
In Commercial Distribution

  • M90107RD7065321 ()
  • M90107RD7065320 ()

  • Length: 75 Millimeter
07RD7065-32

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

QuickProfile™ Drugs of Abuse Panel 6 Test - M90107RD7065310

Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BUP / COC / M-AMP / OPI / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7065-31
In Commercial Distribution

  • M90107RD7065311 ()
  • M90107RD7065310 ()

  • Length: 75 Millimeter
07RD7065-31

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

QuickProfile™ Drugs of Abuse Panel 6 Test - M90107RD7065280

Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / M-AMP / MTD / OPI / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7065-28
In Commercial Distribution

  • M90107RD7065281 ()
  • M90107RD7065280 ()

  • Length: 75 Millimeter
07RD7065-28

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

QuickProfile™ Drugs of Abuse Panel 3 Test - M90107RD7062020

Immunoassay for the detection of the following drug substance(s) in human urine: COC / M-AMP / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7062-02
In Commercial Distribution

  • M90107RD7062021 ()
  • M90107RD7062020 ()

  • Length: 75 Millimeter
07RD7062-02

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

QuickProfile™ Drugs of Abuse Panel 2 Test - M90107RD706104A0

Immunoassay for the detection of the following drug substance(s) in human urine: BZD / OPI-2000
LUMIQUICK DIAGNOSTICS, INC.
07RD7061-04A
In Commercial Distribution

  • M90107RD706104A1 ()
  • M90107RD706104A0 ()

  • Length: 75 Millimeter
07RD7061-04A

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

QuickProfile™ Drugs of Abuse Panel 2 Test - M90107RD7061030

Immunoassay for the detection of the following drug substance(s) in human urine: MAMP / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7061-03
In Commercial Distribution

  • M90107RD7061031 ()
  • M90107RD7061030 ()

  • Length: 75 Millimeter
07RD7061-03

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

QuickProfile™ Drugs of Abuse Panel 2 Test - M90107RD7061010

Immunoassay for the detection of the following drug substance(s) in human urine: COC / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7061-01
In Commercial Distribution

  • M90107RD7061011 ()
  • M90107RD7061010 ()

  • Length: 75 Millimeter
07RD7061-01

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

QuickProfile™ PCP Test Card - M90107RD70220

Immunoassay for the detection of PCP in human urine
LUMIQUICK DIAGNOSTICS, INC.
07RD7022
In Commercial Distribution

  • M90107RD70221 ()
  • M90107RD70220 ()

  • Length: 75 Millimeter
07RD7022

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

Precise Sapphire - M896PRSAP0600

Precise Sapphire - 60 mL LR Kit
ARTERIOCYTE MEDICAL SYSTEMS, INC.
PRC-SAP-060
In Commercial Distribution

  • M896PRCSAP0601 ()
  • M896PRSAP0600 ()


  • Haematological concentrate system preparation kit, platelet concentration

Precise Sapphire - M896PRCSAP1200

Precise Sapphire - 120 mL LR Kit
ARTERIOCYTE MEDICAL SYSTEMS, INC.
PRC-SAP-120
In Commercial Distribution

  • M896PRCSAP1201 ()
  • M896PRCSAP1200 ()


  • Haematological concentrate system preparation kit, platelet concentration

Precise Diamond - M896PRCDIA1200

Precise Diamond - 120 mL LP Kit
ARTERIOCYTE MEDICAL SYSTEMS, INC.
PRC-DIA-120
In Commercial Distribution

  • M896PRCDIA1201 ()
  • M896PRCDIA1200 ()


  • Haematological concentrate system preparation kit, platelet concentration

Precise Diamond - M896PRCDIA0600

Precise Diamond - 60 mL LP Kit
ARTERIOCYTE MEDICAL SYSTEMS, INC.
PRC-DIA-060
In Commercial Distribution

  • M896PRCDIA0600 ()
  • M896PRCDIA0601 ()


  • Haematological concentrate system preparation kit, platelet concentration

Autologous Serum Dispenser Kit - M896MSD4050

Sterile Disposable Kit containing single-patient-use components necessary for each platelet separation procedure with the MAGELLAN® Autologous Platelet Separator Instrument.
ARTERIOCYTE MEDICAL SYSTEMS, INC.
MSD405
Not in Commercial Distribution

  • M896MSD4050 ()
  • M896MSD4051 ()
MSD405

  • Haematological concentrate system preparation kit, platelet concentration

Ratio Dispenser Kit - M896MRD5050

Sterile Disposable Kit containing single-patient-use components necessary for each platelet separation procedure with the MAGELLAN® Autologous Platelet Separator Instrument.
ARTERIOCYTE MEDICAL SYSTEMS, INC.
MRD505
In Commercial Distribution

  • M896MRD5050 ()
  • M896MRD5051 ()
MRD505

  • Haematological concentrate system preparation kit, platelet concentration

Basic Platelet Separator Kit - M896MDK3050

Sterile Disposable Kit containing single-patient-use components necessary for each platelet separation procedure with the MAGELLAN® Autologous Platelet Separator Instrument.
ARTERIOCYTE MEDICAL SYSTEMS, INC.
MDK305
In Commercial Distribution

  • M896MDK3050 ()
  • M896MDK3051 ()
MDK305

  • Haematological concentrate system preparation kit, platelet concentration

Magellan Complete Disposable Kit - M896MDK300JPN0

No Description
ARTERIOCYTE MEDICAL SYSTEMS, INC.
MDK300-JPN
In Commercial Distribution

  • M896MDK300JPN0 ()
  • M896MDK300JPN1 ()


  • Haematological concentrate system preparation kit, platelet concentration
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