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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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Misago® - 04987350722225

MISAGO RX Self-expanding Peripheral Stent
TERUMO CORPORATION
SXR07100L
In Commercial Distribution

  • 54987350722220 ()
  • 04987350722225 ()

  • Distal Tip and Sheath are coated with Hydrophilic Polymer
  • Catheter Usable Length: 135 centimeters
  • Length: 100 Millimeter
  • Lumen/Inner Diameter: 7 Millimeter
SX*FXA07X0LN

  • Peripheral artery stent, bare-metal

Misago® - 04987350722201

MISAGO RX Self-expanding Peripheral Stent
TERUMO CORPORATION
SXR07080L
In Commercial Distribution

  • 54987350722206 ()
  • 04987350722201 ()

  • Distal Tip and Sheath are coated with Hydrophilic Polymer
  • Catheter Usable Length: 135 centimeters
  • Length: 80 Millimeter
  • Lumen/Inner Diameter: 7 Millimeter
SX*FXA0780LN

  • Peripheral artery stent, bare-metal

Misago® - 04987350722188

MISAGO RX Self-expanding Peripheral Stent
TERUMO CORPORATION
SXR07060L
In Commercial Distribution

  • 54987350722183 ()
  • 04987350722188 ()

  • Distal Tip and Sheath are coated with Hydrophilic Polymer
  • Catheter Usable Length: 135 centimeters
  • Length: 60 Millimeter
  • Lumen/Inner Diameter: 7 Millimeter
SX*FXA0760LN

  • Peripheral artery stent, bare-metal

Misago® - 04987350722164

MISAGO RX Self-expanding Peripheral Stent
TERUMO CORPORATION
SXR07040L
In Commercial Distribution

  • 54987350722169 ()
  • 04987350722164 ()

  • Distal Tip and Sheath are coated with Hydrophilic Polymer
  • Catheter Usable Length: 135 centimeters
  • Length: 40 Millimeter
  • Lumen/Inner Diameter: 7 Millimeter
SX*FXA0740LN

  • Peripheral artery stent, bare-metal

Misago® - 04987350722140

MISAGO RX Self-expanding Peripheral Stent
TERUMO CORPORATION
SXR06150L
In Commercial Distribution

  • 54987350722145 ()
  • 04987350722140 ()

  • Distal Tip and Sheath are coated with Hydrophilic Polymer
  • Catheter Usable Length: 135 centimeters
  • Length: 150 Millimeter
  • Lumen/Inner Diameter: 6 Millimeter
SX*FXA06X5LN

  • Peripheral artery stent, bare-metal

Misago® - 04987350722126

MISAGO RX Self-expanding Peripheral Stent
TERUMO CORPORATION
SXR06120L
In Commercial Distribution

  • 54987350722121 ()
  • 04987350722126 ()

  • Distal Tip and Sheath are coated with Hydrophilic Polymer
  • Catheter Usable Length: 135 centimeters
  • Length: 120 Millimeter
  • Lumen/Inner Diameter: 6 Millimeter
SX*FXA06X2LN

  • Peripheral artery stent, bare-metal

EL-ANA PROFILES: ANA/9 - 00854473003071

ANTI-NUCLEAR ANTIBODY ELISA TEST KIT, 40 TESTS OF 9 INDIVIDUAL ANTIGENS
THERA-TEST LABORATORIES, INC
104-005
In Commercial Distribution

  • 00854473003071 ()
104-005

  • Centromere protein antibody (anti-CENP) IVD, kit, enzyme immunoassay (EIA)
  • Scleroderma-70 antibody (anti-Scl-70) IVD, kit, enzyme immunoassay (EIA)
  • Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, kit, enzyme immunoassay (EIA)
  • SSB/La antibody (Sjogren's antibody) IVD, kit, enzyme immunoassay (EIA)
  • SSA/Ro antibody (Sjogren's antibody) IVD, kit, enzyme immunoassay (EIA)
  • Sm/RNP antibody IVD, kit, enzyme immunoassay (EIA)
  • Smith antibody (anti-Sm) IVD, kit, enzyme immunoassay (EIA)
  • Double stranded DNA antibody (anti-dsDNA) IVD, kit, enzyme immunoassay (EIA)
  • Single stranded DNA antibody (anti-ssDNA) IVD, kit, enzyme immunoassay (EIA)

Rayner Cataract Set 9 - 05404027444574

No Description
Hasa Optix
HA-SET009
In Commercial Distribution

  • 05404027446592 ()
  • 05404027444574 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use

Global Reference Module 9 - 00850011306598

The Global Reference Module 9 provides Global Referencing to the ATLAS Neurophysiology System. It connects to the Global Reference Connection on the ATLAS Combo Board.
NEURALYNX, INC.
Global Reference Module - 9
In Commercial Distribution

  • 00850011306598 ()
31-0604-0051

  • Electroencephalographic signal amplifier

9" Stainless Steel Guidewire - 00858406007570

No Description
SURGENTEC, LLC
FC-G-16S
In Commercial Distribution

  • 00858406007570 ()


  • Spinal guidewire

Sealing Cap (Size 9) - 00858395006417

Sealing Caps attach to the Molar Procedure Instrument in order to properly setup the Procedure Instrument for teeth of different pulp chamber depths. The Sealing Caps include a color-coded surface to match the proper Sealing Cap to the proper Depth Gauge. Additionally, Sealing Caps feature a sealing element intended to keep air out of the root canal system and procedure fluid inside the tooth.
SONENDO, INC.
FG-001-00009
In Commercial Distribution

  • 00858395006417 ()
  • 00858395006141 ()
GW-MOL-SP09

  • Dental delivery system instrument unit, electric

Sealing Cap (Size 9) - 00858395006073

Sealing Caps attach to the Molar Procedure Instrument in order to properly setup the Procedure Instrument for teeth of different pulp chamber depths. The Sealing Caps include a color-coded surface to match the proper Sealing Cap to the proper Depth Gauge. Additionally, Sealing Caps feature a sealing element intended to keep air out of the root canal system and procedure fluid inside the tooth.
SONENDO, INC.
FG-001-00009
In Commercial Distribution

  • 00858395006073 ()
  • 00858395006141 ()
GW-MOL-SP09

  • Dental delivery system instrument unit, electric

BICRO-LITE ANKLE 9" MEDIUM - 00610570121519

No Description
Bird & Cronin, LLC
99000583
In Commercial Distribution

  • 00610570121519 ()


  • Ankle/foot orthosis

9" ABDOMINAL BINDER 55-72" - 00610570107285

No Description
Bird & Cronin, LLC
BC 0372
In Commercial Distribution

  • 00610570107285 ()


  • Abdominal binder, single-use

9" ABDOMINAL BINDER 46-62" - 00610570107278

No Description
Bird & Cronin, LLC
BC 0362
In Commercial Distribution

  • 00610570107278 ()


  • Abdominal binder, single-use

Origin Size 9 Template - 09348215074722

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-109
In Commercial Distribution

  • 09348215074722 ()


  • Surgical implant template, reusable

Aria Size 9 Template - 09348215073572

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-201-509
In Commercial Distribution

  • 09348215073572 ()


  • Surgical implant template, reusable

Tap Shaft Size 9 - 09348215068356

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
132-112-185
In Commercial Distribution

  • 09348215068356 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable

Victory 9 4 Wheel - 00606509300384

A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.
Pride Mobility Products Corp
SC709/S709
In Commercial Distribution

  • 00606509300384 ()
N/A

  • Assistive scooter, electric-motor-driven

Victory 9 3 Wheel - 00606509300377

A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.
Pride Mobility Products Corp
SC609/S609
In Commercial Distribution

  • 00606509300377 ()
N/A

  • Assistive scooter, electric-motor-driven

Zirconia ECO LINE 9 - D800ZRAE0501

No Description
ZIRKONZAHN SRL
ZRAE0501
In Commercial Distribution

  • D800ZRAE0501 ()


  • Dental bridge, ceramic

Prettau® Zirconia 9 - D800ZRAD0501

Content: 1 piece Height: 16 mm Highly translucent zirconia for single crowns to large bridges (fully anatomic structures or reduced structures for veneering with ceramics)
ZIRKONZAHN SRL
ZRAD0501
In Commercial Distribution

  • D800ZRAD0501 ()


  • Dental bridge, ceramic

ColoCare - 9 Health Fair - M5255521380

No Description
HELENA LABORATORIES CORPORATION
552138
In Commercial Distribution

  • M5255521380 ()


  • Faecal occult blood IVD, kit, rapid colorimetric, clinical

ContrIL 9 Level 3 - 08426950087915

ContrIL 9 Level 3
INSTRUMENTATION LABORATORY COMPANY
00024001421
In Commercial Distribution

  • 08426950087915 ()
  • 18426950087912 ()
00024001421

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

ContrIL 9 Level 2 - 08426950087908

ContrIL 9 Level 2
INSTRUMENTATION LABORATORY COMPANY
00024001420
In Commercial Distribution

  • 08426950087908 ()
  • 18426950087905 ()
00024001420

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

ContrIL 9 Level 1 - 08426950087892

ContrIL 9 Level 1
INSTRUMENTATION LABORATORY COMPANY
00024001419
In Commercial Distribution

  • 08426950087892 ()
  • 18426950087899 ()
00024001419

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

CERVICAL COIL N.9 - 08056304452870

Coil for G-scan Brio
ESAOTE SPA
131000400
In Commercial Distribution

  • 08056304452870 ()


  • MRI system coil, radio-frequency

DEPTH GAUGE 9 mm - 08055727374578

No Description
HPF SRL
9095.11.302
In Commercial Distribution

  • 08055727374578 ()


  • Surgical depth gauge, reusable

DEPTH GAUGE 9 mm - 08055727374561

No Description
HPF SRL
H0010354099
In Commercial Distribution

  • 08055727374561 ()


  • Surgical depth gauge, reusable

Recon Plate, 9 Holes - 00840118103411

Compatible with 2.7mm/3.5mm screws, implants for orthopedic bone fixation
FLOWER ORTHOPEDICS CORPORATION
FRP 709
In Commercial Distribution

  • 00840118103411 ()

  • Height: 2.5 Millimeter


  • Orthopaedic fixation plate, non-bioabsorbable
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