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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XactGrid, 64 Contact, Platinum, 8x8, 2 Tails, 5mm Spacing
BLACKROCK MICROSYSTEMS, LLC
027692
In Commercial Distribution

  • 00814901020568 ()

  • 8x8, 2 Tails, 5mm Spacing
027692

  • Cortical electrode
XactGrid, 48 Contact, Platinum, 6x8, 2 Tails, 5mm Spacing
BLACKROCK MICROSYSTEMS, LLC
027691
In Commercial Distribution

  • 00814901020551 ()

  • 6x8, 2 Tails, 5mm Spacing
027691

  • Cortical electrode
XactGrid, 32 Contact, Platinum, 4x8, 1 Tail, 5mm Spacing
BLACKROCK MICROSYSTEMS, LLC
027690
In Commercial Distribution

  • 00814901020544 ()

  • 4x8, 1 Tail, 5mm Spacing
027690

  • Cortical electrode
XactGrid, 24 Contact, Platinum, 4x6, 1 Tail, 5mm Spacing
BLACKROCK MICROSYSTEMS, LLC
026689
In Commercial Distribution

  • 00814901020537 ()

  • 4x6, 1 Tail, 5mm Spacing
026689

  • Cortical electrode
XactGrid, 16 Contact, Platinum, 4x4, 1 Tail, 5mm Spacing
BLACKROCK MICROSYSTEMS, LLC
028943
In Commercial Distribution

  • 00814901020520 ()

  • 4x4, 1 Tail, 5mm Spacing
028943

  • Cortical electrode
XactGrid, 16 Contact, Platinum, 2x8, 1 Tail, 5mm Spacing
BLACKROCK MICROSYSTEMS, LLC
027687
In Commercial Distribution

  • 00814901020513 ()

  • 2x8, 1 Tail, 5mm Spacing
027687

  • Cortical electrode
XactGrid, 8 Contact, Platinum, 2x4, 1 Tail, 5mm Spacing
BLACKROCK MICROSYSTEMS, LLC
027686
In Commercial Distribution

  • 00814901020506 ()

  • 2x4, 1 Tail, 5mm Spacing
027686

  • Cortical electrode
XactGrid, 20 Contact, Platinum, 2x10, 1 Tail, 5mm Spacing
BLACKROCK MICROSYSTEMS, LLC
026688
In Commercial Distribution

  • 00814901020490 ()

  • 2x10, 1 Tail, 5mm Spacing
026688

  • Cortical electrode
XactGrid, 20 Contact, Platinum, 4x5, 1 Tail, 5mm Spacing
BLACKROCK MICROSYSTEMS, LLC
028944
In Commercial Distribution

  • 00814901020483 ()

  • 4x5, 1 Tail, 5mm Spacing
028944

  • Cortical electrode
Peripheral Nerve Stimulation Lead Kit (8 contact, 60 cm)
NALU MEDICAL, INC.
72012
In Commercial Distribution

  • 00812537037233 ()

  • Length: 60 Centimeter
72012

  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection
Peripheral Nerve Stimulation Lead Kit (8 contact, 40 cm)
NALU MEDICAL, INC.
72011
In Commercial Distribution

  • 00812537037226 ()

  • Length: 40 Centimeter
72011

  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection
Peripheral Nerve Stimulation Lead (4 contact, 40 cm, Tined)
NALU MEDICAL, INC.
12005-040-US
In Commercial Distribution

  • 00812537036281 ()

  • Length: 40 Centimeter
12005-040-US

  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection
Peripheral Nerve Stimulation Lead (4 contact, 25 cm, Tined)
NALU MEDICAL, INC.
12005-025-US
In Commercial Distribution

  • 00812537036274 ()

  • Length: 25 Centimeter
12005-025-US

  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection
Peripheral Nerve Stimulation Lead Kit (8 contact, 60 cm)
NALU MEDICAL, INC.
72012-US
In Commercial Distribution

  • 00812537035642 ()

  • Length: 60 Centimeter
72012-US

  • Analgesic implantable peripheral nerve electrical stimulation system
Peripheral Nerve Stimulation Lead Kit (8 contact, 60 cm)
NALU MEDICAL, INC.
72012
In Commercial Distribution

  • 00812537035635 ()

  • Length: 60 Centimeter
72012

  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection
Peripheral Nerve Stimulation Lead Kit (8 contact, 40 cm)
NALU MEDICAL, INC.
72011-US
In Commercial Distribution

  • 00812537035628 ()

  • Length: 40 Centimeter
72011-US

  • Analgesic implantable peripheral nerve electrical stimulation system
Peripheral Nerve Stimulation Lead Kit (8 contact, 40 cm)
NALU MEDICAL, INC.
72011
In Commercial Distribution

  • 00812537035611 ()

  • Length: 40 Centimeter
72011

  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection
Peripheral Nerve Stimulation Lead (4 contact, 40 cm, Tined)
NALU MEDICAL, INC.
12005-040-US
In Commercial Distribution

  • 00812537035567 ()

  • Length: 40 Centimeter
12005-040-US

  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection
Peripheral Nerve Stimulation Lead (4 contact, 40 cm, Tined)
NALU MEDICAL, INC.
12005-040-US
In Commercial Distribution

  • 00812537032986 ()

  • Length: 40 Centimeter
12005-040-US

  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection
Peripheral Nerve Stimulation Lead (4 contact, 40 cm, Tined)
NALU MEDICAL, INC.
12005-040
In Commercial Distribution

  • 10812537032914 ()
  • 00812537032917 ()

  • Length: 40 Centimeter
12005-040

  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection
Peripheral Nerve Stimulation Lead (4 contact, 25 cm, Tined)
NALU MEDICAL, INC.
12005-025-US
In Commercial Distribution

  • 00812537031910 ()

  • Length: 25 Centimeter
12005-025-US

  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection
Peripheral Nerve Stimulation Lead (4 contact, 25 cm, Tined)
NALU MEDICAL, INC.
12005-025
In Commercial Distribution

  • 00812537030630 ()
  • 10812537030637 ()

  • Length: 25 Centimeter
12005-025

  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection
HALYARD* Surgical Cap-4-Ply Tissue with Polyester Reinforcements Fluid Contact
O&M HALYARD, INC.
69240
In Commercial Distribution

  • 30680651692406 ()
  • 20680651692409 ()
  • 90680651692408 ()
69240

  • Surgical cap, single-use
TCC-EZ® TOTAL CONTACT CAST SYSTEM - Large TMA Boot
ACELL, INC.
TCC21131
In Commercial Distribution

  • 00809958009710 ()

  • 4" W x 3.3125"H
  • 10cm x 3.5cm
TCC2-1131

  • Cast boot
TCC-EZ® TOTAL CONTACT CAST SYSTEM - 10 Casting Systems
ACELL, INC.
TCC24001
In Commercial Distribution

  • 00809958006016 ()

  • 4" /10cm
TCC2-4001

  • Cast boot
TCC-EZ® TOTAL CONTACT CAST SYSTEM - 10 Casting Systems
ACELL, INC.
TCC23001
In Commercial Distribution

  • 00809958005217 ()

  • 3" /7.6cm
TCC2-3001

  • Cast boot
TCC-EZ® TOTAL CONTACT CAST SYSTEM - Extra Large Boot
ACELL, INC.
TCC21124
In Commercial Distribution

  • 00809958004913 ()

  • 4" W x 3.3125"H
  • 10cm x 3.5cm
TCC2-1124

  • Cast boot
TCC-EZ® TOTAL CONTACT CAST SYSTEM -Large Charcot Boot
ACELL, INC.
TCC21116
In Commercial Distribution

  • 00809958004814 ()

  • 10cm x 3.5cm
  • 4" W x 3.3125"H
TCC2-1116

  • Cast boot
Positioning aid to prevent direct gantry contact in MRI
Pearl Technology AG
ProFoam MR Safety Angel Pad
In Commercial Distribution

  • 07640178062160 ()
1301

  • Radiological general body-part positioner
A device that is applied to the tip of a contact type tonometer in order to avoid cross-infection between patients. The device is made of plastic. This is a single-use device.
AUTOMATED OPHTHALMICS, INC.
AO316
In Commercial Distribution

  • 00860000603805 ()


  • Ophthalmic tonometer tip cover
Disposable single use prism for FMAT1 Device
FALCK MEDICAL INC
Prism B
In Commercial Distribution

  • 00867009000215 ()
  • 10867009000212 ()
  • 20867009000219 ()

  • Length: 35 Centimeter


  • Ophthalmic tonometer tip cover
Bulk, non-sleeved
ACCUTOME, INC.
AX11286
In Commercial Distribution

  • 00897826002116 ()
  • 00897826002130 ()
AX11286

  • Ophthalmic tonometer tip cover
Sleeved
ACCUTOME, INC.
AX11526
In Commercial Distribution

  • 00897826002109 ()
  • 00897826002130 ()
AX11526

  • Ophthalmic tonometer tip cover
Individually wrapped
ACCUTOME, INC.
AX11932
In Commercial Distribution

  • 00897826002093 ()
  • 00897826002130 ()
AX11932

  • Ophthalmic tonometer tip cover
Individually wrapped
ACCUTOME, INC.
AX9950
In Commercial Distribution

  • 00897826002086 ()
  • 00897826002130 ()
AX9950

  • Ophthalmic tonometer tip cover
The separation prisms is an accessory to the tonometer which is device intended to estimate intraocular pressure by applying a force on the globe of the eye.
LUNEAU TECHNOLOGY OPERATIONS
Tonometer separation prisms L900 -box of 20
In Commercial Distribution

  • 03664188000114 ()
  • 03664188000138 ()


  • Ophthalmic tonometer tip cover
The separation prisms is an accessory to the tonometer which is device intended to estimate intraocular pressure by applying a force on the globe of the eye.
LUNEAU TECHNOLOGY OPERATIONS
Tonometer separation prisms L900 -box of 100
In Commercial Distribution

  • 03664188000107 ()
  • 03664188000114 ()


  • Ophthalmic tonometer tip cover
Single use tonometer tip cover used with Tono-Pen tonometers. Used to protect the transducer from dust and fluids, and helps protect patients from risk of cross-contamination.
REICHERT, INC.
230653
In Commercial Distribution

  • 00812559012096 ()


  • Ophthalmic tonometer tip cover
Single use tonometer tip cover used with Tono-Pen tonometers. Used to protect the transducer from dust and fluids, and helps protect patients from risk of cross-contamination.
REICHERT, INC.
230652
In Commercial Distribution

  • 00812559012089 ()


  • Ophthalmic tonometer tip cover
Single use tonometer tip cover used with Tono-Pen tonometers. Used to protect the transducer from dust and fluids, and helps protect patients from risk of cross-contamination.
REICHERT, INC.
230651
In Commercial Distribution

  • 00812559010115 ()


  • Ophthalmic tonometer tip cover
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