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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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N/A - 00817470007114

JAWS TIGER SHARK GRASPER
Smith & Nephew, Inc.
14-2001
In Commercial Distribution

  • 00817470007114 ()
14-2001

  • Dissection forceps

ARK™ UR-144/JWH-018 Assay - 00812101030257

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)

ARK™ UR-144/JWH-018 Assay - 00812101030240

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)

ICU Medical - 00840619085957

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

ICU Medical - 00840619060305

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

ICU Medical - 00840619060275

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

ICU Medical - 00840619060268

TriOx™ SvO2/CCO PA Catheter, 8F, 110cm, Q-Tip
ICU MEDICAL, INC.
52511
In Commercial Distribution

  • 10840619060265 ()
  • 00840619060268 ()
52511-14

  • Pulmonary artery balloon catheter, oximetric

ICU Medical - 00840619060251

TriOx™ SvO2/CCO PA Catheter, 8F, 110cm, Q-Tip, Heparin Coated, LF
ICU MEDICAL, INC.
52509
In Commercial Distribution

  • 10840619060258 ()
  • 00840619060251 ()
52509-15

  • Pulmonary artery balloon catheter, oximetric

ICU Medical - 00840619060244

TriOx™ SvO2/CCO PA Catheter, 8F, 110cm, Q-Tip, Heparin Coated
ICU MEDICAL, INC.
52509
In Commercial Distribution

  • 10840619060241 ()
  • 00840619060244 ()
52509-14

  • Pulmonary artery balloon catheter, oximetric

ICU Medical - 00840619060237

TriOx™ SO2 Intravascular Catheter P540-H, 5.5F, 40cm, Heparin Coated
ICU MEDICAL, INC.
50407
In Commercial Distribution

  • 10840619060234 ()
  • 00840619060237 ()
50407-02

  • Pulmonary artery balloon catheter, oximetric
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