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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No Description
Microgenics Corporation
CAI-XL1
In Commercial Distribution

  • 00884883002340 ()


  • Multiple cardiac marker IVD, control
No Description
Microgenics Corporation
OCRD-MP
In Commercial Distribution

  • 00884883012004 ()


  • Multiple cardiac marker IVD, control
No Description
Microgenics Corporation
OCRD-303
In Commercial Distribution

  • 00884883011984 ()


  • Multiple cardiac marker IVD, control
No Description
Microgenics Corporation
OCRD-202
In Commercial Distribution

  • 00884883011977 ()


  • Multiple cardiac marker IVD, control
No Description
Microgenics Corporation
OCRD-L
In Commercial Distribution

  • 00884883011953 ()


  • Multiple cardiac marker IVD, control
No Description
Microgenics Corporation
10014182
In Commercial Distribution

  • 00884883004399 ()


  • Multiple cardiac marker IVD, control
No Description
Microgenics Corporation
10014180
In Commercial Distribution

  • 00884883004375 ()


  • Multiple cardiac marker IVD, control
No Description
Microgenics Corporation
CAI-XL4
In Commercial Distribution

  • 00884883003606 ()


  • Multiple cardiac marker IVD, control
No Description
Microgenics Corporation
CAI-XL2
In Commercial Distribution

  • 00884883002357 ()


  • Multiple cardiac marker IVD, control
Triage Cardio2 Panel
QUIDEL CARDIOVASCULAR INC.
97500EU
In Commercial Distribution

  • 30014613337973 ()
97500EU

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
Triage Cardio3 Panel
QUIDEL CARDIOVASCULAR INC.
97400EU
In Commercial Distribution

  • 30014613337966 ()
97400EU

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
Triage Profiler SOB Panel (OUS)
QUIDEL CARDIOVASCULAR INC.
97300EU
In Commercial Distribution

  • 30014613337959 ()
97300EU

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
Triage Cardiac Panel (CK/TnI)
QUIDEL CARDIOVASCULAR INC.
97022HS
In Commercial Distribution

  • 30014613337942 ()
97022HS

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
Triage Cardiac Panel (OUS)
QUIDEL CARDIOVASCULAR INC.
97000HSEU
In Commercial Distribution

  • 30014613337928 ()
97000HSEU

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
Triage Cardiac Panel
QUIDEL CARDIOVASCULAR INC.
97000HS
In Commercial Distribution

  • 30014613337911 ()
97000HS

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
Quidel Triage Total 5 Calibration Verification
QUIDEL CARDIOVASCULAR INC.
88755
In Commercial Distribution

  • 30014613337126 ()
88755

  • Multiple cardiac marker IVD, control
Quidel Triage Total 5 Control 2
QUIDEL CARDIOVASCULAR INC.
88754
In Commercial Distribution

  • 30014613337119 ()
88754

  • Multiple cardiac marker IVD, control
Quidel Triage Total 5 Control 1
QUIDEL CARDIOVASCULAR INC.
88753
In Commercial Distribution

  • 30014613337102 ()
88753

  • Multiple cardiac marker IVD, control
Quidel Triage Total 3 Control 2
QUIDEL CARDIOVASCULAR INC.
88734
In Commercial Distribution

  • 30014613337096 ()
88734

  • Multiple cardiac marker IVD, control
Quidel Triage Total 3 Control 1
QUIDEL CARDIOVASCULAR INC.
88733
In Commercial Distribution

  • 30014613337089 ()
88733

  • Multiple cardiac marker IVD, control
No Description
CRITICAL CARE DIAGNOSTICS, INC.
BC-1066x
In Commercial Distribution

  • 00867556000195 ()


  • Multiple cardiac marker IVD, kit, enzyme immunoassay (EIA)
No Description
CRITICAL CARE DIAGNOSTICS, INC.
BC-1065
In Commercial Distribution

  • 00867556000188 ()


  • Multiple cardiac marker IVD, kit, enzyme immunoassay (EIA)
No Description
CRITICAL CARE DIAGNOSTICS, INC.
BC-1066
In Commercial Distribution

  • 00867556000157 ()


  • Multiple cardiac marker IVD, kit, enzyme immunoassay (EIA)
The VIDAS ® Creatine Kinase MB (CKMB) Assay is intended for use on the VIDAS instruments for the determination of creatine kinase MB isoenzyme concentration in serum or plasma.
BIOMERIEUX SA
30421-01
Not in Commercial Distribution

  • 03573026161613 ()


  • Multiple cardiac marker IVD, kit, enzyme immunoassay (EIA)
Mass Creatine Kinase MB Isoenzyme Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10444895
In Commercial Distribution

  • 00842768013898 ()
  • 00630414003863 ()
RF520

  • Multiple cardiac marker IVD, kit, enzyme immunoassay (EIA)
Mass Creatine Kinase MB Isoenzyme Flex® reagent cartridge, 160 tests
Siemens Healthcare Diagnostics Inc.
10444904
In Commercial Distribution

  • 00842768013829 ()
  • 00630414003924 ()
RF420

  • Multiple cardiac marker IVD, kit, enzyme immunoassay (EIA)
Creatine Kinase MB Isoenzyme Flex® reagent cartridge, 120 Tests
Siemens Healthcare Diagnostics Inc.
10464339
In Commercial Distribution

  • 00842768027918 ()
  • 00630414005577 ()
K3032

  • Multiple cardiac marker IVD, kit, enzyme immunoassay (EIA)
SILK BB 3/0 18" C6-PEARSON
Surgical Specialties México, S. de R.L. de C.V.
PL784B
In Commercial Distribution

  • 10848782005724 ()
  • 00848782005727 ()

  • 3-0 USP


  • Silk suture
SILK BB 4/0 18" C6-PEARSON
Surgical Specialties México, S. de R.L. de C.V.
PL781B
In Commercial Distribution

  • 10848782005717 ()
  • 00848782005710 ()

  • 4-0 USP


  • Silk suture
SILK BB 3/0 18" C26-PEARSON
Surgical Specialties México, S. de R.L. de C.V.
PL778B
In Commercial Distribution

  • 10848782007896 ()
  • 00848782007899 ()

  • 3-0 USP


  • Silk suture
SILK BB 3/0 18" C31-PEARSON
Surgical Specialties México, S. de R.L. de C.V.
PL785B
In Commercial Distribution

  • 10848782007889 ()
  • 00848782007882 ()

  • 3-0 USP


  • Silk suture
003-2479 Silk Bb 5-0 18" Dsm13
Surgical Specialties México, S. de R.L. de C.V.
ZG-0020N
In Commercial Distribution

  • 10848782022899 ()
  • 00848782022892 ()

  • 5-0 USP
003-2479

  • Silk suture
003-2491 Silk Bb 3-0 18" Ds24
Surgical Specialties México, S. de R.L. de C.V.
ZG-0014N
In Commercial Distribution

  • 10848782022868 ()
  • 00848782022861 ()

  • 3-0 USP
003-2491

  • Silk suture
003-2492 Silk Bb 4-0 18" Dsm13
Surgical Specialties México, S. de R.L. de C.V.
ZG-0013N
In Commercial Distribution

  • 10848782022851 ()
  • 00848782022854 ()

  • 4-0 USP
003-2492

  • Silk suture
003-2486 Silk Bb 3-0 18" Hs16
Surgical Specialties México, S. de R.L. de C.V.
ZG-0009N
In Commercial Distribution

  • 10848782022813 ()
  • 00848782022816 ()

  • 3-0 USP
003-2486

  • Silk suture
003-2487 Silk Bb 3-0 18" Ds18
Surgical Specialties México, S. de R.L. de C.V.
ZG-0008N
In Commercial Distribution

  • 10848782022806 ()
  • 00848782022809 ()

  • 3-0 USP
003-2487

  • Silk suture
003-2489 Silk Bb 4-0 18" Ds18
Surgical Specialties México, S. de R.L. de C.V.
ZG-0007N
In Commercial Distribution

  • 10848782022790 ()
  • 00848782022793 ()

  • 4-0 USP
003-2489

  • Silk suture
003-2488 Silk Bb 3-0 18" Hs24
Surgical Specialties México, S. de R.L. de C.V.
ZG-0003N
In Commercial Distribution

  • 10848782022752 ()
  • 00848782022755 ()

  • 3-0 USP
003-2488

  • Silk suture
MDNG-5121 BB MA GE BUC MKII
Barco NV
MDNG-5121
Not in Commercial Distribution

  • 05415334001473 ()
K9300268B

  • Radiology picture archiving and communication system workstation
SAFARI 900, BTE 13 P BB
Oticon A/S
103-40-305-00
In Commercial Distribution

  • 05707131149671 ()


  • Air-conduction hearing aid, behind-the-ear
SAFARI 600, BTE 13 P BB
Oticon A/S
103-40-405-00
In Commercial Distribution

  • 05707131149497 ()


  • Air-conduction hearing aid, behind-the-ear
SAFARI 300, BTE 13 P BB
Oticon A/S
103-40-505-00
In Commercial Distribution

  • 05707131149312 ()


  • Air-conduction hearing aid, behind-the-ear
VGPC, RITE BB VIGO PRO CONNECT
Oticon A/S
104-38-105-00
In Commercial Distribution

  • 05707131141279 ()


  • Air-conduction hearing aid, receiver-in-the-ear
VGC, BTE 13 BB VIGO CONNECT
Oticon A/S
103-38-605-00
In Commercial Distribution

  • 05707131140616 ()


  • Air-conduction hearing aid, behind-the-ear
VGPC, BTE BB VIGO PRO CONNECT
Oticon A/S
103-38-015-00
In Commercial Distribution

  • 05707131140111 ()


  • Air-conduction hearing aid, behind-the-ear
HIT PRO, BTE 13 P BB
Oticon A/S
103-36-305-00
In Commercial Distribution

  • 05707131131843 ()


  • Air-conduction hearing aid, behind-the-ear
SENSEI, BTE 13 WL 90 BB
Oticon A/S
131225
In Commercial Distribution

  • 05707131255853 ()


  • Air-conduction hearing aid, behind-the-ear
SENSEI, BTE 312 WL 75 BB
Oticon A/S
131203
In Commercial Distribution

  • 05707131255747 ()


  • Air-conduction hearing aid, behind-the-ear
SENSEI PRO, RITE 312 WL BB
Oticon A/S
129844
In Commercial Distribution

  • 05707131255372 ()


  • Air-conduction hearing aid, receiver-in-the-ear
Appsync Body Composition Scale (BB&B)
Greater Goods
0341
In Commercial Distribution

  • 10875011003411 ()
  • 00875011003414 ()


  • Stand-on floor scale, electronic
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