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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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ViperWire, Advance, Extended Length, Peripheral, 0.014" Dia spring tip, 475cm, 5 Pack
Cardiovascular Systems, Inc.
VPR-GW-EL14
In Commercial Distribution

  • 30852528005453 ()
  • 10852528005459 ()

  • Length: 475 Centimeter
  • Shaft Diameter 0.014 inches
  • Max Tip Diameter 0.014 inches
7-10035-01

  • Peripheral vascular guidewire, manual
Alice 5 Thermistor
Ambu A/S
814910-121
In Commercial Distribution

  • 05707480042180 ()
814910-121

  • Polysomnograph
Ref. 1464
Ambu A/S
814310-121
Not in Commercial Distribution

  • 05707480042043 ()
814310-121

  • Polysomnograph
DrugSmart Cup 5, AMP/COC/OPI/PCP/THC, 25 tests/kit
CHEMTRON BIOTECH INC
60505D
In Commercial Distribution

  • 00850019007664 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Single use coring needle for retrieval of tissue samples. It is placed through a flexible bronchoscope.
BRONCUS MEDICAL INC.
10005-2
In Commercial Distribution

  • 00856571007210 ()

  • Needle Gauge: 18 Gauge
10005-2

  • Soft-tissue biopsy needle, single-use
Surround 5.x
Gpi Usa, Inc.
5.x
In Commercial Distribution



  • Blood bank information system
Lateral flow immunoassay for the detection of drugs of abuse in urine: Cocaine (COC), Amphetamine (AMP), Methamphetamine (mAMP), Marijuana (THC), Opiates (OPI).
GERMAINE LABORATORIES, INC
45625
In Commercial Distribution

  • 00695684456252 ()
  • 00695684456251 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical
  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
AirSep FreeStyle 5 Portable Oxygen Concentrator, 1-5LPM, External Battery, Re-Manufactured
CAIRE INC.
AS077-101CU
In Commercial Distribution

  • M766AS077101CU0 ()


  • Mobile/portable oxygen concentrator
No Description
Merit Medical Systems, Inc.
00884450487211
In Commercial Distribution

  • 10884450487218 ()
  • 00884450487211 ()

  • Balloon Outer Diameters-17 mm, 18 mm, 19 mm, 20 mm, 21 mm
EPCX18

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated
No Description
Merit Medical Systems, Inc.
00884450487204
In Commercial Distribution

  • 10884450487201 ()
  • 00884450487204 ()

  • Balloon Outer Diameters-14 mm, 15 mm, 16.5 mm, 18 mm, 19 mm
EPCX15

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated
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