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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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Elite Elastic Bandage - 00840155407633

Elite, Elastic Bandage, 6 / Elite First Aid Part Number: 503
MEDSOURCE INTERNATIONAL LLC
ELITE-EB006
In Commercial Distribution

  • 00840155407701 ()
  • 00840155407633 ()
  • 00840155407770 ()
Not Applicable

  • Non-adhesive device retention bandage

Elite Elastic Bandage - 00840155407626

Elite, Elastic Bandage 2 / Elite First Aid Part Number: 500
MEDSOURCE INTERNATIONAL LLC
ELITE-EB002
In Commercial Distribution

  • 00840155407626 ()
  • 00840155407695 ()
  • 00840155407763 ()
Not Applicable

  • Non-adhesive device retention bandage

Specboard - B852SPECBOARD4440

Device Classification Name System, X-Ray, Mammographic 510(K) Number K891090
MACBRUD CORPORATION
444
In Commercial Distribution

  • B852SPECBOARD4440 ()


  • Stationary x-ray grid

Wellness - 00819835024125

Wellness - Kegel Training Kit - Purple Part Number: BL-444004 Material: Silicone
Blush Novelties
Wellness - Kegel Training Kit - Purple
In Commercial Distribution

  • 00819835024125 ()
BL-444004

  • Perineometer

Wellness - 00819835023425

Wellness - Dilator Kit - Purple Part Number: BL-444111 Material Type: Silicone
Blush Novelties
Wellness - Dilator Kit - Purple
In Commercial Distribution

  • 00819835023425 ()
BL-444111

  • Vaginal dilator

VTI 8 MHZ Disposable Doppler Probe, Box - 10817122020468

Part Number 108280, VTI 8 MHZ Disposable Doppler Probe, Box
VASCULAR TECHNOLOGY, INCORPORATED
108280
In Commercial Distribution

  • 10817122020468 ()
  • 00817122020461 ()
108280

  • Invasive/noninvasive vascular ultrasound probe

Mizuho 07-150-12 20 MHz Micro Disposable Doppler Probe, Box - 10817122020338

Part Number 138665, 20 Mhz Micro Disposable Doppler Probe, Box
VASCULAR TECHNOLOGY, INCORPORATED
138665
In Commercial Distribution

  • 10817122020338 ()
  • 00817122020331 ()
138665

  • Invasive/noninvasive vascular ultrasound probe

Mizuho 07-150-21 20 MHz Disposable Doppler Probe Straight, Box - 10817122020284

Part Number 138220, 20 MHz Disposable Doppler Probe Straight, Box
VASCULAR TECHNOLOGY, INCORPORATED
138220
In Commercial Distribution

  • 10817122020284 ()
  • 00817122020287 ()
138220

  • Invasive/noninvasive vascular ultrasound probe

8 MHz Kelly Endonasal Disposable Doppler Probe, Box - 10817122020277

Part Number 138210, 8 MHz Kelly Endonasal Doppler Probe, Box
VASCULAR TECHNOLOGY, INCORPORATED
138210
In Commercial Distribution

  • 10817122020277 ()
  • 00817122020270 ()
138210

  • Invasive/noninvasive vascular ultrasound probe

Edwards FLO-003S Ultrasonic Blood Flow Detector Straight Probe, Box - 10817122020253

Part Number 128361, Ultrasonic Blood Flow Detector Straight Probe, Box
VASCULAR TECHNOLOGY, INCORPORATED
128361
Not in Commercial Distribution

  • 10817122020253 ()
  • 00817122020256 ()
128361

  • Invasive/noninvasive vascular ultrasound probe

Edwards FLO-002S Ultrasonic Blood Flow Detector Curved Probe, Box - 10817122020246

Part Number 128360, Ultrasonic Blood Flow Detector Curved Probe, Box
VASCULAR TECHNOLOGY, INCORPORATED
128360
Not in Commercial Distribution

  • 10817122020246 ()
  • 00817122020249 ()
128360

  • Invasive/noninvasive vascular ultrasound probe

VTI 20 MHz Disposable Doppler Probe, Box - 10817122020239

Part Number 108665, VTI 20 MHz Disposable Doppler Probe, Box
VASCULAR TECHNOLOGY, INCORPORATED
108665
In Commercial Distribution

  • 10817122020239 ()
  • 00817122020232 ()
108665

  • Invasive/noninvasive vascular ultrasound probe

Mizuho 07-150-22 20 MHz Disposable Doppler Probe Curved Tip, Box - 10817122020192

Part Number 138230 20 MHz Disposable Doppler Probe Curved, Box
VASCULAR TECHNOLOGY, INCORPORATED
138230
In Commercial Distribution

  • 10817122020192 ()
  • 00817122020195 ()
138230

  • Invasive/noninvasive vascular ultrasound probe

Remotely Operated Suction & Irrigation Tubing Set, Box - 10817122020031

Part Number 106410, Remotely Operated Suction Irrigation Tubing Set, Box
VASCULAR TECHNOLOGY, INCORPORATED
106410
In Commercial Distribution

  • 10817122020031 ()
  • 00817122020034 ()
106410

  • Surgical irrigation/aspiration tubing set

Simplex - 07613327128444

Full Dose Bone Cement, 10 pack catalog number is 6191-1-010
Howmedica Osteonics Corp.
6191-1-001
In Commercial Distribution

  • 37613327128445 ()
  • 07613327128444 ()
  • 57613327128449 ()

  • Weight: 40.0 Gram
  • Total Volume: 20.0 Milliliter
6191-1-001

  • Orthopaedic cement, non-antimicrobial

Simplex - 07613327128437

Half Dose Bone Cement, 10 pack catalog number is 6188-1-010
Howmedica Osteonics Corp.
6188-1-001
In Commercial Distribution

  • 57613327128432 ()
  • 37613327128438 ()
  • 07613327128437 ()

  • Total Volume: 10.0 Milliliter
  • Weight: 20.0 Gram
6188-1-001

  • Orthopaedic cement, non-antimicrobial

Delice - 00810138370834

Delice - Chéri - Kegel Trainer - Purple Part Number: BL-23721 Material: Silicone
Blush Novelties
Delice - Chéri - Kegel Trainer - Purple
In Commercial Distribution

  • 00810138370834 ()
BL-23721

  • Perineometer

Surgical Direct - B382SD1105000200

5mm 45cm Bipolar Rippled Bar Insert for item number SD110510000
Surgical Direct, Inc.
SD110500020
In Commercial Distribution

  • B382SD1105000200 ()
SD110500020

  • Endoscopic electrosurgical handpiece/electrode, bipolar, reusable

Surgical Direct - B382SD1105000100

5mm 33cm Bipolar Rippled Bar Insert for item number SD110510000
Surgical Direct, Inc.
SD110500010
In Commercial Distribution

  • B382SD1105000100 ()
SD110500010

  • Endoscopic electrosurgical handpiece/electrode, bipolar, reusable

VTI 8 MHz TRANS-Q-TANEOUS Intraoperative Doppler Transceiver - 00817122020508

Part Number 108800, VTI 8 MHz TRANS-Q-TANEOUS Intraoperative Doppler Transceiver
VASCULAR TECHNOLOGY, INCORPORATED
108800
In Commercial Distribution

  • 00817122020508 ()
  • 00817122020638 ()
108800

  • Vascular ultrasound system control unit
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