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
DIASORIN MOLECULAR LLC
MOL2160
In Commercial Distribution

  • 20816101025514 ()
MOL2160

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control
No Description
DIASORIN MOLECULAR LLC
MOL2150
In Commercial Distribution

  • 20816101025507 ()
MOL2150

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
DIASORIN MOLECULAR LLC
SC1100
In Commercial Distribution

  • 20816101025101 ()
SC1100

  • Optical laboratory instrument performance standard calibrator/control IVD, reusable
LINEARITY KIT 313-50 HEPLINE
MEDTRONIC, INC.
313-50
In Commercial Distribution

  • 00763000014902 ()


  • Coagulation timer IVD
ENACEM HF+BONDING COMPLETE KIT 1 COS101 1 Ena Etch Orthophosphoric acid 37% 2ml 1 COSM101K CANULA 0,4 x 18mm. 1 COSM300A2 ENABOND Bonding Agent MONO 2ml 1 COSM300D-2 ENABOND Catalyst 2ml 5 COSM3A-1 ORANGE NEEDLETUBE 20 gauge 5 COSM3P-1 PLUG for NEEDLETUBE 20 gauge 1 CPC-3UD1 ENACEM HF DUAL CEMENT UD1 3g 1 CPC-3UD2 ENACEM HF DUAL CEMENT UD2 3g 1 CPC-3UD3 ENACEM HF DUAL CEMENT UD3 3g 1 CPC-3UD4 ENACEM HF DUAL CEMENT UD4 3g 5 CPCTIPL-1 White Syringe needle 8 CPCTIPN-1 AUTOMIX ENACEM needle 4 CPCTIPS-1 Intraoral Syringe Needle
MICERIUM SPA
CPCK
In Commercial Distribution

  • EMICCPCK1 ()
CPCK

  • Glass ionomer dental cement
  • Dental prosthesis-component adhesive
ENA-BOND SE KIT Bonding + Primer -1 CFOTS-2 (2 ml) -1 CFOTP-2 (2 ml)
MICERIUM SPA
CFOTX
In Commercial Distribution

  • EMICCFOTX1 ()

  • Total Volume: 4 Milliliter
CFOTX

  • Dentine bonding agent/set
ENA-BOND SE LIGHT CURING BONDING 2 ml
MICERIUM SPA
CFOTS-2
In Commercial Distribution

  • EMICCFOTS20 ()

  • Total Volume: 2 Milliliter
CFOTS-2

  • Dentine bonding agent/set
ENA-BOND SE LIGHT CURING BONDING 5 ml
MICERIUM SPA
CFOTS
In Commercial Distribution

  • EMICCFOTS1 ()

  • Total Volume: 5 Milliliter
CFOTS

  • Dentine bonding agent/set
ENA-BOND SE LIGHT CURING BONDING 5 ml
MICERIUM SPA
CFOTS
In Commercial Distribution

  • EMICCFOTS0 ()

  • Total Volume: 5 Milliliter
CFOTS

  • Dentine bonding agent/set
ENA-BOND SE Primer 2 ml
MICERIUM SPA
CFOTP-2
In Commercial Distribution

  • EMICCFOTP20 ()

  • Total Volume: 2 Milliliter
CFOTP-2

  • Dentine bonding agent/set
ENA-BOND SE Primer 5 ml
MICERIUM SPA
CFOTP
In Commercial Distribution

  • EMICCFOTP1 ()

  • Total Volume: 5 Milliliter
CFOTP

  • Dentine bonding agent/set
ENA-BOND SE Primer 5 ml
MICERIUM SPA
CFOTP
In Commercial Distribution

  • EMICCFOTP0 ()

  • Total Volume: 5 Milliliter
CFOTP

  • Dentine bonding agent/set
ENA-BOND SE BONDING KIT Adesive + Primer + Etching Gel -1 CFOTS (5 ml) -1 CFOTP (5 ml) -1 COS101 (2 ml)
MICERIUM SPA
CFOTK
In Commercial Distribution

  • EMICCFOTK1 ()

  • Total Volume: 12 Milliliter
CFOTK

  • Dentine bonding agent/set
ENA-BOND SE KIT Bonding + Primer -1 CFOTS (5 ml) -1 CFOTP (5 ml)
MICERIUM SPA
CFOT
In Commercial Distribution

  • EMICCFOT1 ()

  • Total Volume: 10 Milliliter
CFOT

  • Dentine bonding agent/set
Vysis ALK Break Apart FISH Probe Kit
ABBOTT MOLECULAR INC.
06N38-053
In Commercial Distribution

  • 00884999042773 ()
06N38-053

  • Anaplastic lymphoma kinase (ALK) genetic mutation IVD, probe
Vysis ALK Break Apart FISH Probe Kit
ABBOTT MOLECULAR INC.
06N38-033
In Commercial Distribution

  • 00884999042728 ()
06N38-033

  • Anaplastic lymphoma kinase (ALK) genetic mutation IVD, probe
Abbott RealTime HBV Amplification Reagent Kit
ABBOTT MOLECULAR INC.
2N40-91
In Commercial Distribution

  • 00884999038462 ()
2N40-91

  • Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
DNA Amp Check
ABBOTT MOLECULAR INC.
8L49-030
In Commercial Distribution

  • 00884999031357 ()
8L49-30

  • Endogenous DNA/RNA internal control IVD, reagent
Abbott RealTime CT/NG Amplification Reagent Kit
ABBOTT MOLECULAR INC.
8L07-91
In Commercial Distribution

  • 00884999031142 ()
8L07-91

  • Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Abbott RealTime CT/NG Control Kit
ABBOTT MOLECULAR INC.
8L07-80
In Commercial Distribution

  • 00884999031128 ()
8L07-80

  • Multiple-type sexually transmitted pathogen nucleic acid IVD, control
Vysis ALK Break Apart FISH Probe Kit
ABBOTT MOLECULAR INC.
06N38-020
In Commercial Distribution

  • 00884999025745 ()
06N38-020

  • Anaplastic lymphoma kinase (ALK) genetic mutation IVD, probe
Vysis LSI PDGFRB (Tel) SpectrumGreen Probe
ABBOTT MOLECULAR INC.
06N23-010
In Commercial Distribution

  • 00884999025578 ()
06N23-010

  • Nucleic acid hybridization detection IVD, probe
Vysis LSI PDGFRB (Cen) SpectrumOrange Probe
ABBOTT MOLECULAR INC.
06N22-010
In Commercial Distribution

  • 00884999025561 ()
06N22-010

  • Nucleic acid hybridization detection IVD, probe
Vysis BRAF SpectrumGold Probe
ABBOTT MOLECULAR INC.
06N09-001
In Commercial Distribution

  • 00884999025011 ()
06N09-001

  • Nucleic acid hybridization detection IVD, probe
Vysis MET SpectrumRed Probe
ABBOTT MOLECULAR INC.
06N05-001
In Commercial Distribution

  • 00884999024977 ()
06N05-001

  • Nucleic acid hybridization detection IVD, probe
Abbott RealTime HIV-1 Amplification Reagent Kit
ABBOTT MOLECULAR INC.
6L18-90
In Commercial Distribution

  • 00884999023949 ()
6L18-90

  • HIV1 nucleic acid IVD, kit, nucleic acid technique (NAT)
Abbott RealTime HIV-1 Control Kit
ABBOTT MOLECULAR INC.
6L18-80
In Commercial Distribution

  • 00884999023932 ()
6L18-80

  • HIV1 nucleic acid IVD, control
Abbott RealTime HIV-1 Calibrator Kit
ABBOTT MOLECULAR INC.
6L18-70
In Commercial Distribution

  • 00884999023925 ()
6L18-70

  • HIV1 nucleic acid IVD, calibrator
Vysis LSI RUNX1 SpectrumGreen Probe
ABBOTT MOLECULAR INC.
05N98-010
In Commercial Distribution

  • 00884999015500 ()
05N98-010

  • Nucleic acid hybridization detection IVD, probe
Vysis EGR1 FISH Probe Kit
ABBOTT MOLECULAR INC.
04N37-020
In Commercial Distribution

  • 00884999008366 ()
04N37-020

  • Acute myeloid leukaemia (AML) genetic mutation IVD, probe
Vysis CLL FISH Probe Kit
ABBOTT MOLECULAR INC.
04N02-020
In Commercial Distribution

  • 00884999007772 ()
04N02-020

  • Chronic lymphocytic leukaemia (CLL) genetic mutation IVD, probe
Abbott m2000rt Optical Calibration Kit
ABBOTT MOLECULAR INC.
04J71-93
In Commercial Distribution

  • 00884999006577 ()
04J71-93

  • Thermal cycler nucleic acid instrument calibrator/control kit IVD
Abbott RealTime HBV Amplification Reagent Kit
ABBOTT MOLECULAR INC.
2N40-90
In Commercial Distribution

  • 00884999003071 ()
2N40-90

  • Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Abbott RealTime HBV Control Kit
ABBOTT MOLECULAR INC.
2N40-80
In Commercial Distribution

  • 00884999003064 ()
2N40-80

  • Hepatitis B virus nucleic acid IVD, control
Abbott RealTime HBV Calibrator Kit
ABBOTT MOLECULAR INC.
2N40-70
In Commercial Distribution

  • 00884999003057 ()
2N40-70

  • Hepatitis B virus nucleic acid IVD, calibrator
Abbott RealTime HCV Amplification Reagent Kit
ABBOTT MOLECULAR INC.
1N30-90
In Commercial Distribution

  • 00884999000728 ()
1N30-90

  • Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Abbott RealTime HCV Control Kit
ABBOTT MOLECULAR INC.
1N30-80
In Commercial Distribution

  • 00884999000711 ()
1N30-80

  • Hepatitis C virus nucleic acid IVD, control
Abbott RealTime HCV Calibrator Kit
ABBOTT MOLECULAR INC.
1N30-70
In Commercial Distribution

  • 00884999000704 ()
1N30-70

  • Hepatitis C virus nucleic acid IVD, calibrator
DAU 2 V3 UCSD
UTAK LABORATORIES, INC.
DAU LEVEL 2 V3
In Commercial Distribution

  • B800DAU2V3UCSD5 ()
  • B800DAU2V3UCSD0 ()

  • Total Volume: 1.5 Milliliter
DAU LEVEL 2 V3

  • Multiple-type clinical chemistry analyte profile IVD, control
DAU LEVEL 1 V3
UTAK LABORATORIES, INC.
DAU 1 V3 UCSD
In Commercial Distribution

  • B800DAU1V3UCSD5 ()
  • B800DAU1V3UCSD0 ()

  • Total Volume: 1.5 Milliliter
DAU 1 V3 UCSD

  • Multiple-type clinical chemistry analyte profile IVD, control
TRICYCLICS LEVEL 2 V2
UTAK LABORATORIES, INC.
TCA L2 V2 S MAYO
In Commercial Distribution

  • B800TCAL2V2SMAYO5 ()
  • B800TCAL2V2SMAYO0 ()

  • Total Volume: 1 Milliliter
TCA L2 V2 S MAYO

  • Multiple antidepressant therapeutic drug monitoring IVD, control
Tray Liner 10 x 10
General Hospital Supply Corp
S1010
In Commercial Distribution

  • 10850045406346 ()
  • 00850045406349 ()
S1010

  • Instrument tray liner
CIF 14x18, 10 deg, -10
Zavation LLC
23-1010
In Commercial Distribution

  • 00197157003029 ()


  • Polymeric spinal interbody fusion cage
SIZER, 10 DEG, 10 & 11MM
SPINAL ELEMENTS
170-2000-11
In Commercial Distribution

  • 00840916139926 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
HP CARBIDE 10 - 10 PACK
Ss White Burs, Inc.
HP-PBUR-SC10
In Commercial Distribution

  • D690148460 ()
  • D690148462 ()
14846

  • Carbide dental bur, single-use
#10 Pre-Formed Clasp Pkg 10
Keystone Industries
1271100
In Commercial Distribution

  • H66812711000 ()
  • H66812711001 ()
1271100

  • Denture clasp, metal, preformed
Spacer 15x17.5, 10 deg, -10
Zavation LLC
171-1010
In Commercial Distribution

  • 00842166112223 ()


  • Polymeric spinal interbody fusion cage
Spacer 12x15, 10 deg, -10
Zavation LLC
170-1010
In Commercial Distribution

  • 00842166111738 ()


  • Polymeric spinal interbody fusion cage
CIF 14x16, 10 deg, -10
Zavation LLC
22-1010
In Commercial Distribution

  • 00842166105270 ()


  • Polymeric spinal interbody fusion cage
CIF 13x15, 10 deg, -10
Zavation LLC
21-1010
In Commercial Distribution

  • 00842166104716 ()


  • Polymeric spinal interbody fusion cage
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