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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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Colon Cleansing Nozzle with Flex Tube
LIFESTREAM PURIFICATION SYSTEM LLC
SP0001
In Commercial Distribution

  • B149SP00011 ()
  • B149SP0001 ()
  • SP00010 ()
SP0001

  • Colonic lavage nozzle, sterile
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)
Stone Basket, 2.5 Fr., w/o tip, straight
Karl Storz GmbH & Co. KG
27023LD
In Commercial Distribution

  • 04048551390238 ()
  • 04048551390245 ()


  • Biliary stone retrieval basket
Stone Basket, 3 Fr., w/o tip, straight
Karl Storz GmbH & Co. KG
27023LF
In Commercial Distribution

  • 04048551390184 ()


  • Biliary stone retrieval basket
Stone Basket, 3 Fr., w/o tip, straight
Karl Storz GmbH & Co. KG
27023KF
In Commercial Distribution

  • 04048551390160 ()


  • Biliary stone retrieval basket
OptiQ, SvO2/CCO Catheter, 8F, 110 cm, J-Tip, Heparin Coated
ICU MEDICAL, INC.
886-52510-14
In Commercial Distribution

  • 10840619079342 ()
  • 00840619079345 ()
886-52510-14

  • Pulmonary artery balloon catheter, oximetric
Opticath Catheter P7110-EH, 7.5F, 110 cm, Heparin Coated
ICU MEDICAL, INC.
886-50324-07
In Commercial Distribution

  • 10840619085954 ()
  • 00840619085957 ()
886-50324-07

  • Pulmonary artery balloon catheter, oximetric
TriOx™ SvO2/CCO PA Catheter, 8F, 110cm, J-Tip, LF
ICU MEDICAL, INC.
52516
In Commercial Distribution

  • 10840619060302 ()
  • 00840619060305 ()
52516-15

  • Pulmonary artery balloon catheter, oximetric
TriOx™ SvO2/CCO PA Catheter, 8F, 110cm, Q-Tip, LF
ICU MEDICAL, INC.
52511
In Commercial Distribution

  • 10840619060272 ()
  • 00840619060275 ()
52511-15

  • Pulmonary artery balloon catheter, oximetric
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