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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Supply Hose
W & H Dentalwerk Bürmoos GmbH
30180003
In Commercial Distribution

  • J021301800031 ()


  • Dental delivery system instrument unit, electric
  • Dental surgical power tool motor, electric
Electric Handpiece Motor
W & H Dentalwerk Bürmoos GmbH
30178000
In Commercial Distribution

  • J021301780001 ()


  • Dental surgical power tool motor, electric
  • Dental delivery system instrument unit, electric
REAR MOUNT LAMINATE WORKSURFACE & WALL MOUNT PANEL SIDE DELIVERY, DESIGNER FRIENDLY (UPCHARGE APPLIES)
Ls Enterprises, Inc.
3386WM-C
In Commercial Distribution

  • D0693386WMC0 ()


  • Dental delivery system
COMPACT CONTROL, PANEL MOUNT, 2 HP AUTO, MCC LESS HP TUBING & HOLDER BAR
Ls Enterprises, Inc.
2521MCC-G
In Commercial Distribution

  • D0692521MCCG0 ()


  • Dental delivery system
COMPACT CONTROL, PANEL MOUNT, 2 HP AUTO, MCC LESS HP TUBING & HOLDER BAR
Ls Enterprises, Inc.
2521MCC
In Commercial Distribution

  • D0692521MCC0 ()


  • Dental delivery system
WORKSURFACE, REAR BENEATH COUNTER W/DUO UNIT LEFT/RIGHT & UNDER WORKSURFACE PANEL CONTROL
Ls Enterprises, Inc.
2186BC
In Commercial Distribution

  • D0692186BC0 ()


  • Dental delivery system
No Description
GREAT BASIN SCIENTIFIC, INC.
GBSIDR-10
In Commercial Distribution

  • B178GBSIDR102 ()
  • B178GBSIDR100 ()
GBSIDR-10

  • MRSA/MSSA nucleic acid IVD, kit, nucleic acid technique (NAT)
  • MRSE nucleic acid detection IVD, kit, nucleic acid technique (NAT)
  • Multiple Staphylococcus bacterial species culture isolate identification IVD, kit
  • MRSA nucleic acid IVD, kit, nucleic acid technique (NAT)
The T2Bacteria component that contains the refrigerated reagents used to perform the T2Bacteria panel.
T2 BIOSYSTEMS, INC.
80-07342
In Commercial Distribution

  • M70880073423 ()
  • M70880050580 ()


  • Multiple-type bloodstream pathogen nucleic acid IVD, reagent
The T2Candida component that contains the refrigerated reagents used to perform the T2Candida panel.
T2 BIOSYSTEMS, INC.
80-01689
In Commercial Distribution

  • M70880016893 ()
  • M70880009660 ()


  • Multiple Candida species nucleic acid IVD, reagent
Buffer based solution with containing non-pathogenic bacterial strains with the T2Biothreat Panel target sequences.
T2 BIOSYSTEMS, INC.
85-11396
In Commercial Distribution

  • M70883113950 ()
  • M70885113963 ()


  • Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, control
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