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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

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

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

BICRO-LITE ANKLE 9" MEDIUM - 00610570121519

No Description
Bird & Cronin, LLC
99000583
In Commercial Distribution

  • 00610570121519 ()


  • Ankle/foot orthosis

9" ABDOMINAL BINDER 46-62" - 00610570107278

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

  • 00610570107278 ()


  • Abdominal binder, single-use

9" ABDOMINAL BINDER 55-72" - 00610570107285

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

  • 00610570107285 ()


  • Abdominal binder, single-use

Rayner Cataract Set 9 - 05404027444574

No Description
Hasa Optix
HA-SET009
In Commercial Distribution

  • 05404027446592 ()
  • 05404027444574 ()


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

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

9" Stainless Steel Guidewire - 00858406007570

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

  • 00858406007570 ()


  • Spinal guidewire

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)

Recon Plate, 9 Holes, - 00840118103602

Compatible with 2.7mm/3.5mm screws, implants for orthopedic bone fixation
FLOWER ORTHOPEDICS CORPORATION
FRP 935
In Commercial Distribution

  • 00840118103602 ()

  • Height: 3.7 Millimeter


  • Orthopaedic fixation plate, non-bioabsorbable

Recon Plate, 9 Holes - 00840118103510

Compatible with 2.7mm/3.5mm screws, implants for orthopedic bone fixation
FLOWER ORTHOPEDICS CORPORATION
FRP 909
In Commercial Distribution

  • 00840118103510 ()

  • Height: 3.2 Millimeter


  • Orthopaedic fixation plate, non-bioabsorbable

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

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

DEPTH GAUGE 9 mm - 08055727374578

No Description
HPF SRL
9095.11.302
In Commercial Distribution

  • 08055727374578 ()


  • Surgical depth gauge, reusable

DOA 9 PANEL TEST - 00817830022207

Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD / BUP / COC / M-AMP / MTD / OPI / THC
RAPID DIAGNOSTICS INC
07RD7072-02
In Commercial Distribution

  • 00817830022207 ()

  • Length: 75 Millimeter
07RD7072-02

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

DOA 9 PANEL TEST - 00817830022184

Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD / COC / M-AMP / MTD / OPI / PCP / THC
RAPID DIAGNOSTICS INC
07RD7072-01
In Commercial Distribution

  • 00817830022184 ()

  • Length: 75 Millimeter
07RD7072-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

DOA 9 PANEL TEST - 00817830022221

Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BUP / BZD / COC / MTD / OPI / OXY / THC
RAPID DIAGNOSTICS INC
07RD7072-06
In Commercial Distribution

  • 00817830022221 ()

  • Length: 75 Millimeter
07RD7072-06

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

DOA 9 PANEL TEST - 00817830022214

Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD / BUP / COC / M-AMP / MTD / OPI-II / THC
RAPID DIAGNOSTICS INC
07RD7072-02A
In Commercial Distribution

  • 00817830022214 ()

  • Length: 75 Millimeter
07RD7072-02A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

DOA 9 PANEL TEST - 00817830022191

Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD / COC / M-AMP / MTD / OPI-II/ PCP / THC
RAPID DIAGNOSTICS INC
07RD7072-01A
In Commercial Distribution

  • 00817830022191 ()

  • Length: 75 Millimeter
07RD7072-01A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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