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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Intraurethral Valve-Pump
VESIFLO INC
March 2017
In Commercial Distribution

  • 00862563003122 ()
203511-50

  • Intraurethral valve/pump
Intraurethral Valve-Pump
VESIFLO INC
March 2017
In Commercial Distribution

  • 00862563003115 ()
203511-45

  • Intraurethral valve/pump
Intraurethral Valve-Pump
VESIFLO INC
March 2017
In Commercial Distribution

  • 00862563003108 ()
203511-40

  • Intraurethral valve/pump
Intraurethral Valve-Pump
VESIFLO INC
March 2017
In Commercial Distribution

  • 00862563003092 ()
203511-35

  • Intraurethral valve/pump
Intraurethral Valve-Pump
VESIFLO INC
March 2017
In Commercial Distribution

  • 00862563003085 ()
203511-30

  • Intraurethral valve/pump
Urethral measurement device, female.
VESIFLO INC
March 2017
In Commercial Distribution

  • 00862563003078 ()
203511-SD

  • Intraurethral valve/pump
No Description
LAURIMED, LLC
4.0mm Microdebrider
In Commercial Distribution

  • 00862519000328 ()
  • 00862519000335 ()
FG-000017

  • ENT shaver system handpiece
No Description
LAURIMED, LLC
3.3mm Microdebrider
In Commercial Distribution

  • 00862519000304 ()
  • 00862519000311 ()
FG-000016

  • ENT shaver system handpiece
No Description
PRO-DEX, INC.
KLS-SD-1000-NTL
In Commercial Distribution

  • 00862377000188 ()


  • Bone/joint surgical power tool motorized handpiece/set, electric, reusable
No Description
PRO-DEX, INC.
APD-1000-1
In Commercial Distribution

  • 00862377000164 ()


  • Bone/joint surgical power tool motorized handpiece/set, electric, reusable
No Description
PRO-DEX, INC.
KLS-SD-1000
In Commercial Distribution

  • 00862377000133 ()


  • Bone/joint surgical power tool motorized handpiece/set, electric, reusable
No Description
PRO-DEX, INC.
05.000.020
In Commercial Distribution

  • 00862377000102 ()


  • Bone/joint surgical power tool motorized handpiece/set, electric, reusable
Tens Unit Black
VIVE HEALTH LLC
RHB1006BLK
In Commercial Distribution

  • 10861470000399 ()
  • 00861470000392 ()


  • Intramuscular injection site nerve-locating/electromyography system
Digital Scale (Black)
VIVE HEALTH LLC
DMD1002BLK
In Commercial Distribution

  • 10861470000337 ()
  • 00861470000330 ()


  • Stand-on floor scale, mechanical
Blood Pressure Monitor Black
VIVE HEALTH LLC
DMD1001BLK
Not in Commercial Distribution

  • 00861470000323 ()
  • 10861470000320 ()


  • Physiologic-monitoring defibrillation system
Safer Lock Box - Black
Rxguardian Inc.
1000085
In Commercial Distribution

  • 00861121000085 ()


  • Medicine bottle cap
  • Medicine bottle
The Bebe Vie is a single-use pediatric laryngoscope for intubation of toddlers to age ten.
ADROIT SURGICAL
BB-111
In Commercial Distribution

  • 00860115000612 ()
  • 00860115000681 ()


  • Rigid intubation laryngoscope, single-use
The Vie Scope is a single-use intubation device whose transparent polymer tubing and LED lights allow for an enhanced line of sight.
ADROIT SURGICAL
VS-103
In Commercial Distribution

  • 00860115000605 ()
  • 00860115000629 ()


  • Rigid intubation laryngoscope, single-use
Skin Morcellation Device
TISSUEMILL TECHNOLOGIES LLC
260-07797
In Commercial Distribution

  • 00860013994006 ()


  • Dermatome blade, single-use
No Description
Armor Dental Corp.
83209-SPU
In Commercial Distribution

  • 00860013984632 ()


  • Hand-held dental retractor
No Description
Armor Dental Corp.
83211
In Commercial Distribution

  • 00860013984625 ()


  • Hand-held dental retractor
No Description
Armor Dental Corp.
83210
In Commercial Distribution

  • 00860013984618 ()


  • Hand-held dental retractor
No Description
Armor Dental Corp.
83209-AC
In Commercial Distribution

  • 00860013984601 ()


  • Hand-held dental retractor
Tendon Seam™ Instrument Kit - 4 Anchor
Integrity Orthopaedics, Inc
901005
In Commercial Distribution

  • 00860013905972 ()
901005

  • Orthopaedic inorganic implant inserter/extractor, single-use
  • Tendon/ligament bone anchor, non-bioabsorbable
Delivery Instrument, included with Tendon Seam™ Instrument Kit - 4 Anchor
Integrity Orthopaedics, Inc
902001
In Commercial Distribution

  • 00860013905965 ()
902001

  • Orthopaedic inorganic implant inserter/extractor, single-use
Tendon Seam™ Instrument Kit - 8 Anchor
Integrity Orthopaedics, Inc
901003
In Commercial Distribution

  • 00860013905934 ()
901003

  • Orthopaedic inorganic implant inserter/extractor, single-use
  • Tendon/ligament bone anchor, non-bioabsorbable
Delivery Instrument, included with Tendon Seam™ Instrument Kit - 8 Anchor
Integrity Orthopaedics, Inc
902001
In Commercial Distribution

  • 00860013905927 ()
902001

  • Orthopaedic inorganic implant inserter/extractor, single-use
Vu-Max (Pederson), Large
REAL STAR SURGICAL INSTRUMENTS
RSSI-130-114
In Commercial Distribution

  • 00860012999699 ()


  • Vaginal speculum, reusable
Vu-Max (Pederson) , Medium
REAL STAR SURGICAL INSTRUMENTS
RSSI-130-115
In Commercial Distribution

  • 00860012999682 ()


  • Vaginal speculum, reusable
Pederson Vaginal Speculum, Large
REAL STAR SURGICAL INSTRUMENTS
RSSI-130-200
In Commercial Distribution

  • 00860012999675 ()


  • Vaginal speculum, reusable
Pederson Vaginal Speculum, Medium
REAL STAR SURGICAL INSTRUMENTS
RSSI-130-202
In Commercial Distribution

  • 00860012999668 ()


  • Vaginal speculum, reusable
Pederson Vaginal Speculum, Small
REAL STAR SURGICAL INSTRUMENTS
RSSI-130-203
In Commercial Distribution

  • 00860012999651 ()


  • Vaginal speculum, reusable
Graves Vaginal Speculum, X-Large
REAL STAR SURGICAL INSTRUMENTS
RSSI-130-104
In Commercial Distribution

  • 00860012999644 ()


  • Vaginal speculum, reusable
Graves Vaginal Speculum, Small
REAL STAR SURGICAL INSTRUMENTS
RSSI-130-103
In Commercial Distribution

  • 00860012999637 ()


  • Vaginal speculum, reusable
Graves Vaginal Speculum, Medium
REAL STAR SURGICAL INSTRUMENTS
RSSI-130-102
In Commercial Distribution

  • 00860012999620 ()


  • Vaginal speculum, reusable
Graves Vaginal Speculum , Large
REAL STAR SURGICAL INSTRUMENTS
RSSI-130-100
In Commercial Distribution

  • 00860012999613 ()


  • Vaginal speculum, reusable
Emmett Hook
REAL STAR SURGICAL INSTRUMENTS
RSSI-130-170
In Commercial Distribution

  • 00860012999606 ()


  • Surgical soft-tissue manipulation forceps, scissors-like, reusable
OXYGEN CONCENTRATOR(Model: CP101), 44.6 lbs, Gray + blue + black, to provide supplemental oxygen to patients with respiratory disorders.
Foshan MIC Medical Technology Co.,Ltd.
CP101
In Commercial Distribution

  • 00860012953332 ()


  • Mobile/portable oxygen concentrator
OXYGEN CONCENTRATOR(Model: CP502), 32 lbs, Grey + Dark grey + black, to provide supplemental oxygen to patients with respiratory disorders.
Foshan MIC Medical Technology Co.,Ltd.
CP502
In Commercial Distribution

  • 00860012953318 ()


  • Mobile/portable oxygen concentrator
OXYGEN CONCENTRATOR(Model: CP501), 32 lbs, Grey + White + black, to provide supplemental oxygen to patients with respiratory disorders.
Foshan MIC Medical Technology Co.,Ltd.
CP501
In Commercial Distribution

  • 00860012953301 ()


  • Mobile/portable oxygen concentrator
BladeClear Small Shaver Accessory
PATHWAY MEDTECH, LLC
BCS-01
In Commercial Distribution

  • 00860012804412 ()
BCS-01

  • Luminal device flushing tubing set, single-use
BladeClear Large Shaver Accessory
PATHWAY MEDTECH, LLC
BCD-01
In Commercial Distribution

  • 00860012804405 ()
BCD-01

  • Luminal device flushing tubing set, single-use
No Description
Orthodoxo LLC
2077.02422
In Commercial Distribution

  • 00860012754892 ()


  • Arthroscopic shaver system blade, single-use
No Description
Orthodoxo LLC
2077.02421
In Commercial Distribution

  • 00860012754885 ()


  • Arthroscopic shaver system blade, single-use
No Description
Orthodoxo LLC
2077.01424
In Commercial Distribution

  • 00860012754878 ()


  • Arthroscopic shaver system blade, single-use
No Description
Orthodoxo LLC
2077.01423
In Commercial Distribution

  • 00860012754861 ()


  • Arthroscopic shaver system blade, single-use
No Description
Orthodoxo LLC
2077.01422
In Commercial Distribution

  • 00860012754854 ()


  • Arthroscopic shaver system blade, single-use
No Description
Orthodoxo LLC
2077.02302
In Commercial Distribution

  • 00860012754847 ()


  • Arthroscopic shaver system blade, single-use
No Description
Orthodoxo LLC
2077.02301
In Commercial Distribution

  • 00860012754830 ()


  • Arthroscopic shaver system blade, single-use
No Description
Orthodoxo LLC
2077.01304
In Commercial Distribution

  • 00860012754823 ()


  • Arthroscopic shaver system blade, single-use
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