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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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Easy Release is an infusion set to connect to SOOIL's insulin reservoir for using insulin pump. It is inserted in the subcutaneous tissue and Not intended for use into blood vessel.
SOOIL DEVELOPMENT CO.,LTD
SU303
In Commercial Distribution

  • 08809220580185 ()
  • 08809220580550 ()
  • 08809220580833 ()

  • Weight: 6.4 Gram
  • Outer Diameter: 1.5 Millimeter
  • Needle Gauge: 27 Gauge
  • Length: 100 Millimeter


  • Ambulatory insulin infusion pump, electronic
Easy Release is an infusion set to connect to SOOIL's insulin reservoir for using insulin pump. It is inserted in the subcutaneous tissue and Not intended for use into blood vessel.
SOOIL DEVELOPMENT CO.,LTD
SU302
In Commercial Distribution

  • 08809220580178 ()
  • 08809220580543 ()
  • 08809220580826 ()

  • Weight: 6.4 Gram
  • Outer Diameter: 1.5 Millimeter
  • Needle Gauge: 27 Gauge
  • Length: 100 Millimeter


  • Ambulatory insulin infusion pump, electronic
Easy Release is an infusion set to connect to SOOIL's insulin reservoir for using insulin pump. It is inserted in the subcutaneous tissue and Not intended for use into blood vessel.
SOOIL DEVELOPMENT CO.,LTD
SU301
In Commercial Distribution

  • 08809220580086 ()
  • 08809220580536 ()
  • 08809220580819 ()

  • Outer Diameter: 1.5 Millimeter
  • Needle Gauge: 27 Gauge
  • Length: 100 Millimeter
  • Weight: 6.4 Gram


  • Ambulatory insulin infusion pump, electronic
AZOSTIX® is a firm, plastic strip to which is affixed an impregnated reagent area for estimating the amount of urea nitrogen in whole blood to provide information on renal function.
Siemens Healthcare Diagnostics Inc.
10324060
In Commercial Distribution

  • 00630414551142 ()
  • 00630414009544 ()
A2830C16

  • Urea IVD, kit, enzyme spectrophotometry
This device is an under counter washer disinfector designed for the cleaning, thermal disinfection (intermediate level) and forced hot air drying of instruments used in surgeries, dental instruments and laboratory glassware.
STEELCO SPA
DS 610/2
In Commercial Distribution

  • 08033609173150 ()
DS 610/2

  • Surgical utensil washer/disinfector
Complete Bonding Kit includes 1 bottle of Primer/Unfilled Resin, 1 bottle of Dual-Cure Catalyst, 1 bottle of Unfilled Resin, one #1 brush/straight; and one #1 brush/bent in Tray.
COSMEDENT, INC.
654005
In Commercial Distribution

  • D7796540053 ()
654005

  • Dental composite adhesive kit
Pointe Scientific, Inc. ALT Reagent is for the quantitative determination of Alanine Aminotransferase in serum. Packaged with barcodes for use on AU400, AU480 and AU640. 6 x 67ml, 5 x 17ml.
POINTE SCIENTIFIC, INC.
OA926-487
In Commercial Distribution

  • 00811727014917 ()
OA926-487

  • Alanine aminotransferase (ALT) IVD, kit, enzyme spectrophotometry
The ARK™ UR-144/JWH-018 Assay is an immunoassay intended for the qualitative determination of UR-144/JWH-018 and their metabolites in human urine at a cutoff concentration of 10 ng/mL.
ARK DIAGNOSTICS INC
5054-0001-01
In Commercial Distribution

  • 00812101030257 ()
5054-0001-01

  • Synthetic cannabinoid/synthetic cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
The ARK™ UR-144/JWH-018 Assay is an immunoassay intended for the qualitative determination of UR-144/JWH-018 and their metabolites in human urine at a cutoff concentration of 10 ng/mL.
ARK DIAGNOSTICS INC
5054-0001-00
In Commercial Distribution

  • 00812101030240 ()
5054-0001-00

  • Synthetic cannabinoid/synthetic cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
This device is an under counter washer disinfector designed for the cleaning, thermal disinfection (intermediate level) and forced hot air drying of instruments used in surgeries, dental instruments and laboratory glassware.
STEELCO SPA
TW 3000/2
In Commercial Distribution

  • 08057500819405 ()
TW 3000/2

  • Surgical utensil washer/disinfector
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