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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Cambria Trial, 15x13x8mm, Flat, Line to Line
Seaspine Orthopedics Corporation
93-9938
In Commercial Distribution

  • 10889981055349 ()

  • 15x13x8mm
93-9938

  • Spinal implant trial
Cambria Trial, 15x13x7mm, Flat, Line to Line
Seaspine Orthopedics Corporation
93-9937
In Commercial Distribution

  • 10889981055332 ()

  • 15x13x7mm
93-9937

  • Spinal implant trial
Cambria Trial, 15x13x6mm, Flat, Line to Line
Seaspine Orthopedics Corporation
93-9936
In Commercial Distribution

  • 10889981055325 ()

  • 15x13x6mm
93-9936

  • Spinal implant trial
Cambria Trial, 15x13x5mm, Flat, Line to Line
Seaspine Orthopedics Corporation
93-9935
In Commercial Distribution

  • 10889981055318 ()

  • 15x13x5mm
93-9935

  • Spinal implant trial
Rasp, Line to Line, 17x14, 0°, 12mm
AMEDICA CORPORATION
A
In Commercial Distribution

  • M555910028112 ()

  • Height: 12 Millimeter
  • Width: 14 Millimeter
  • Length: 17 Millimeter
91.002.8112

  • Internal spinal fixation procedure kit, single-use
Rasp, Line to Line, 17x14, 0°, 11mm
AMEDICA CORPORATION
A
In Commercial Distribution

  • M555910028111 ()

  • Length: 17 Millimeter
  • Width: 14 Millimeter
  • Height: 11 Millimeter
91.002.8111

  • Internal spinal fixation procedure kit, single-use
Rasp, Line to Line, 17x14, 0°, 10mm
AMEDICA CORPORATION
A
In Commercial Distribution

  • M555910028110 ()

  • Height: 10 Millimeter
  • Width: 14 Millimeter
  • Length: 17 Millimeter
91.002.8110

  • Internal spinal fixation procedure kit, single-use
Rasp, Line to Line, 17x14, 0°, 9mm
AMEDICA CORPORATION
A
In Commercial Distribution

  • M555910028109 ()

  • Length: 17 Millimeter
  • Width: 14 Millimeter
  • Height: 9 Millimeter
91.002.8109

  • Internal spinal fixation procedure kit, single-use
Rasp, Line to Line, 17x14, 0°, 8mm
AMEDICA CORPORATION
A
In Commercial Distribution

  • M555910028108 ()

  • Height: 8 Millimeter
  • Width: 14 Millimeter
  • Length: 17 Millimeter
91.002.8108

  • Internal spinal fixation procedure kit, single-use
Rasp, Line to Line, 17x14, 0°, 7mm
AMEDICA CORPORATION
A
In Commercial Distribution

  • M555910028107 ()

  • Length: 17 Millimeter
  • Width: 14 Millimeter
  • Height: 7 Millimeter
91.002.8107

  • Internal spinal fixation procedure kit, single-use
Rasp, Line to Line, 17x14, 0°, 6mm
AMEDICA CORPORATION
A
In Commercial Distribution

  • M555910028106 ()

  • Height: 6 Millimeter
  • Width: 14 Millimeter
  • Length: 17 Millimeter
91.002.8106

  • Internal spinal fixation procedure kit, single-use
Rasp, Line to Line, 17x14, 0°, 5mm
AMEDICA CORPORATION
A
In Commercial Distribution

  • M555910028105 ()

  • Length: 17 Millimeter
  • Width: 14 Millimeter
  • Height: 5 Millimeter
91.002.8105

  • Internal spinal fixation procedure kit, single-use
MMC MID LINE/PICC LINE DRESSING CHANGE
MEDLINE INDUSTRIES, INC.
DYNDC3427
In Commercial Distribution

  • 00653160381283 ()
  • 10653160381280 ()
DYNDC3427

  • General surgical procedure kit, medicated
Pressure Monitoring Lines Blue 48" Injection Line w/Male & Female Luer Lock Connectors
ARGON MEDICAL DEVICES, INC.
040504005A
Not in Commercial Distribution

  • 20886333201291 ()
  • 00886333201297 ()

  • 48" Injection Line
040504005A

  • Cardiopulmonary bypass system pressure-monitoring tubing
Pressure Monitoring Lines Red 48" Injection Line w/ Male & Female Luer Lock Connectors
ARGON MEDICAL DEVICES, INC.
040304005A
Not in Commercial Distribution

  • 20886333201284 ()
  • 00886333201280 ()

  • 48" Injection Line
040304005A

  • Radiographic procedure tubing
Pressure Monitoring Lines Pressure Opaque PE Tubing 6Ft. (183cm) Line w/ Male & Female Luer Lock Connectors
ARGON MEDICAL DEVICES, INC.
040106001A
In Commercial Distribution

  • 20886333200966 ()
  • 00886333200962 ()

  • 6Ft. (183cm) Line
040106001A

  • Fluid transfer set, general-purpose
Pressure Monitoring Injection Line 5Ft. M/F
ARGON MEDICAL DEVICES, INC.
040105005A
In Commercial Distribution

  • 20886333200942 ()
  • 00886333200948 ()

  • 5 Ft. line
040105005A

  • Fluid transfer set, general-purpose
Pressure Monitoring Lines 2Ft. (61cm) M/F
ARGON MEDICAL DEVICES, INC.
040102005A
In Commercial Distribution

  • 20886333200850 ()
  • 00886333200856 ()

  • 2Fr. (61cm) Line
040102005A

  • Fluid transfer set, general-purpose
Pressure Opaque PE Tubing 2Ft. Line with Male and Female Luer Lock Connectors
ARGON MEDICAL DEVICES, INC.
040102001A
In Commercial Distribution

  • 20886333200843 ()
  • 00886333200849 ()

  • 2 ft. Line
040102001A

  • Fluid transfer set, general-purpose
Pressure Monitoring Lines 1 Ft. M/F
ARGON MEDICAL DEVICES, INC.
040101005A
In Commercial Distribution

  • 20886333200829 ()
  • 00886333200825 ()

  • 1 Ft. Line
040101005A

  • Fluid transfer set, general-purpose
Pressure Monitoring Lines Pressure Opaque PE Tubing 1 Ft. Line w/ Male & Female Luer Lock Connectors
ARGON MEDICAL DEVICES, INC.
040101001A
In Commercial Distribution

  • 20886333200812 ()
  • 00886333200818 ()

  • 1 Ft. Line
040101001A

  • Fluid transfer set, general-purpose
Pressure Monitoring Lines Pressure Opaque PE Tubing 6" Line (15.2cm) w/Male & Female Luer Lock Connectors
ARGON MEDICAL DEVICES, INC.
040100001A
In Commercial Distribution

  • 20886333200782 ()
  • 00886333200788 ()

  • 6" Line (15.2cm)
040100001A

  • Fluid transfer set, general-purpose
Trifurcate Set 3Way Fluid Administration Set w/6" Main Line
ARGON MEDICAL DEVICES, INC.
039823599A
In Commercial Distribution

  • 20886333200751 ()
  • 00886333200757 ()

  • 6" main line
039823599A

  • Fluid transfer set, general-purpose
TOTALVAC SAMPLE PACK TOTALVAC
Peter Brasseler Holdings, LLC
5030766U0
In Commercial Distribution

  • 00887919957171 ()


  • Endodontic lavage system
TOTALVAC TUBING 20P TOTALVAC
Peter Brasseler Holdings, LLC
5027564U0
In Commercial Distribution

  • 00887919951285 ()


  • Endodontic lavage system
TOTALVAC KIT 25P TOTALVAC
Peter Brasseler Holdings, LLC
5027562U0
In Commercial Distribution

  • 00887919951254 ()


  • Endodontic lavage system
No Description
Vista Dental
6000000
In Commercial Distribution

  • 10818207024388 ()


  • Endodontic lavage system
No Description
Vista Dental
6000001
In Commercial Distribution

  • 10818207024371 ()


  • Endodontic lavage system
No Description
Vista Dental
6000002
In Commercial Distribution

  • 10818207024364 ()


  • Endodontic lavage system
No Description
Vista Dental
407711
In Commercial Distribution

  • 10818207022148 ()


  • Endodontic lavage system
No Description
Vista Dental
407706
In Commercial Distribution

  • 10818207022131 ()


  • Endodontic lavage system
No Description
Vista Dental
407702
In Commercial Distribution

  • 10818207022124 ()


  • Endodontic lavage system
Optiflow Oxygen Kit
FISHER & PAYKEL HEALTHCARE LIMITED
AA451J
In Commercial Distribution

  • 09420012477927 ()
  • 09420012477910 ()
AA451J

  • Humidified oxygen administration set
Endoscopic Valve with Adapter.
APPLIED MEDICAL RESOURCES CORPORATION
SEAL-005
In Commercial Distribution

  • 10607915119901 ()
  • 00607915119904 ()

  • 0-5F


  • Vascular catheter flush valve, continuous
Adapter Seal
APPLIED MEDICAL RESOURCES CORPORATION
B2101
In Commercial Distribution

  • 00607915118297 ()
  • 10607915118294 ()


  • Vascular catheter flush valve, continuous
IV Set-up Line
UTAH MEDICAL PRODUCTS, INC.
Custom
In Commercial Distribution

  • H6719026371 ()
  • H6719026370 ()
902-637

  • Vascular catheter flush valve, continuous
CONTINUOUS FLUSH DEVICE, 3CC/HR FLOW RATE, Y-CONFIGURATION, BLUE W/TAB
UTAH MEDICAL PRODUCTS, INC.
Y-Configuration
In Commercial Distribution

  • H6711002051 ()
  • H6711002050 ()

  • Flow Rate - 3 cc/hr
100-205

  • Vascular catheter flush valve, continuous
CONTINUOUS FLUSH DEVICE, 3CC/HR FLOW RATE, MALE, BLUE, W/TAB
UTAH MEDICAL PRODUCTS, INC.
Male Flow-Through Configuration
In Commercial Distribution

  • H6711002041 ()
  • H6711002040 ()

  • Flow Rate - 3 cc/hr
100-204

  • Vascular catheter flush valve, continuous
CONTINUOUS FLUSH DEVICE, T-CONFIGURATION, 3CC/HR FLOW RATE
UTAH MEDICAL PRODUCTS, INC.
T-Configuration
In Commercial Distribution

  • H6711002021 ()
  • H6711002020 ()

  • Flow Rate - 3 cc/hr
100-202

  • Vascular catheter flush valve, continuous
Line to Line Novel Cervical Trials, L, 11MM
ALPHATEC SPINE, INC.
CI-10305-20-111
In Commercial Distribution

  • 00811801037122 ()


  • Spinal implant trial
Line to Line Novel Cervical Trials, L, 10MM
ALPHATEC SPINE, INC.
CI-10305-20-110
In Commercial Distribution

  • 00811801037115 ()


  • Spinal implant trial
Line to Line Novel Cervical Trials, L, 9MM
ALPHATEC SPINE, INC.
CI-10305-20-109
In Commercial Distribution

  • 00811801037108 ()


  • Spinal implant trial
Line to Line Novel Cervical Trials, L, 8MM
ALPHATEC SPINE, INC.
CI-10305-20-108
In Commercial Distribution

  • 00811801037092 ()


  • Spinal implant trial
Line to Line Novel Cervical Trials, L, 7MM
ALPHATEC SPINE, INC.
CI-10305-20-107
In Commercial Distribution

  • 00811801037085 ()


  • Spinal implant trial
Line to Line Novel Cervical Trials, L, 6MM
ALPHATEC SPINE, INC.
CI-10305-20-106
In Commercial Distribution

  • 00811801037078 ()


  • Spinal implant trial
Line to Line Novel Cervical Trials, L, 5MM
ALPHATEC SPINE, INC.
CI-10305-20-105
In Commercial Distribution

  • 00811801037061 ()


  • Spinal implant trial
Line to Line Novel Cervical Trials, L, 4MM
ALPHATEC SPINE, INC.
CI-10305-20-104
In Commercial Distribution

  • 00811801037054 ()


  • Spinal implant trial
Keeled Tibia Broach, Line to Line, Size 3-8
KYOCERA MEDICAL TECHNOLOGIES, INC.
A 200
In Commercial Distribution

  • 00841523145966 ()
2201-322-911

  • General internal orthopaedic fixation system implantation kit
Keeled Tibia Broach, Line to Line, Size 0-2
KYOCERA MEDICAL TECHNOLOGIES, INC.
A 200
In Commercial Distribution

  • 00841523145959 ()
2201-322-910

  • General internal orthopaedic fixation system implantation kit
No Description
Biomet Orthopedics, LLC
BR101DTS
In Commercial Distribution

  • 00888480429418 ()
  • 70888480429417 ()
BR101DTS

  • Haemodialysis system blood line clamp
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