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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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ALLEN - 00615521015565

S18061PE: Round Post Clamp, EU GE Part Number: 5405559 009
HILL-ROM, INC.
112006
In Commercial Distribution

  • 00615521015565 ()
GE5405559

  • Medical device service rail clamp

ALLEN - 00615521015558

S18061PP: Patient Safety Strap, EU GE Part Number: 5405557 007
HILL-ROM, INC.
112007
In Commercial Distribution

  • 00615521015558 ()
GE5405557

  • Limb/torso/head restraint, reusable

ALLEN - 00615521015473

S18061NP: Patient Safety Strap, US GE Part Number: 5402062 006
HILL-ROM, INC.
112007
In Commercial Distribution

  • 00615521015473 ()
GE5402062

  • Limb/torso/head restraint, reusable

ALLEN - 00615521015459

S18061NE: Round Post Socket, US GE Part Number: 5402060 007
HILL-ROM, INC.
112006
In Commercial Distribution

  • 00615521015459 ()
GE5402060

  • Medical device service rail clamp

Performance Plus - 00850002870695

Performance Plus - Flare - Black / Neon Part Number: BL-92322 Material: Silicone
Blush Novelties
Performance Plus - Flare - Black / Neonck
In Commercial Distribution

  • 00850002870695 ()
BL-92322

  • Penile ring

Performance Plus - 00850002870688

Performance Plus - Takeoff - Red/Black Part Number: BL-92222 Material: Silicone
Blush Novelties
Performance Plus - Takeoff - Red/Black
In Commercial Distribution

  • 00850002870688 ()
BL-92222

  • Penile ring

Power Dental USA - D9434635N0

X POWER CROWN REMOVER™ - R TITANIUM Patent Number D734,852
Power Dental U.S.A. Inc.
4635N
In Commercial Distribution

  • D9434635N0 ()
4635N

  • Dental implant/prosthesis handling forceps
  • Orthodontic pliers

Power Dental USA - D9434634N00

X POWER CROWN REMOVER™ - L TITANIUM Patent Number D734,852
Power Dental U.S.A. Inc.
4634N
In Commercial Distribution

  • D9434634N00 ()
4634N

  • Dental implant/prosthesis handling forceps
  • Orthodontic pliers

HAL for Medical Use - 04560340091084

Number of legs: Double Leg length: Long Hip width: Wide
CYBERDYNE, INC.
HAL-ML05-DLWUS
In Commercial Distribution

  • 04560340091084 ()


  • Neuro-controlled ambulation exoskeleton

HAL for Medical Use - 04560340091077

Number of legs: Double Leg length: Medium Hip width: Wide
CYBERDYNE, INC.
HAL-ML05-DMWUS
In Commercial Distribution

  • 04560340091077 ()


  • Neuro-controlled ambulation exoskeleton

HAL for Medical Use - 04560340091060

Number of legs: Double Leg length: Short Hip width: Wide
CYBERDYNE, INC.
HAL-ML05-DSWUS
In Commercial Distribution

  • 04560340091060 ()


  • Neuro-controlled ambulation exoskeleton

HAL for Medical Use - 04560340090964

Number of legs: Double Leg length: Long Hip width: Medium
CYBERDYNE, INC.
HAL-ML05-DLMUS
In Commercial Distribution

  • 04560340090964 ()


  • Neuro-controlled ambulation exoskeleton

HAL for Medical Use - 04560340090957

Number of legs: Double Leg length: Medium Hip width: Medium
CYBERDYNE, INC.
HAL-ML05-DMMUS
In Commercial Distribution

  • 04560340090957 ()


  • Neuro-controlled ambulation exoskeleton

HAL for Medical Use - 04560340090940

Number of legs: Double Leg length: Short Hip width: Medium
CYBERDYNE, INC.
HAL-ML05-DSMUS
In Commercial Distribution

  • 04560340090940 ()


  • Neuro-controlled ambulation exoskeleton

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

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

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

07-150-02 20 MHz Mizuho Surgical Doppler Transceiver - 00817122020386

Part Number 128160, 07-150-02 20 MHz Mizuho Surgical Doppler Transceiver
VASCULAR TECHNOLOGY, INCORPORATED
128160
In Commercial Distribution

  • 00817122020386 ()
  • 00817122020652 ()
128160

  • Vascular ultrasound system control unit

VTI 20 MHz Surgical Doppler Transceiver, AC - 00817122020348

Part Number 108400-AC, VTI 20 MHz Surgical Doppler Transceiver, AC
VASCULAR TECHNOLOGY, INCORPORATED
108400-AC
In Commercial Distribution

  • 00817122020348 ()
  • 00817122020669 ()
108400-AC

  • Vascular ultrasound system control unit

VTI Remotely Operated Suction & Irrigation System - 00817122020065

PART NUMBER 106400 VTI Remotely Operated Suction & Irrigation System Device
VASCULAR TECHNOLOGY, INCORPORATED
106400
In Commercial Distribution

  • 00817122020065 ()
  • 00817122020614 ()
106400

  • Surgical irrigation/aspiration pump, reusable

Elite Shears - 00816703023310

Elite Shears, EMS, Black / Elite First Aid Part Number: 312
MEDSOURCE INTERNATIONAL LLC
ELITE-SH001B
In Commercial Distribution

  • 00816703023327 ()
  • 00816703023310 ()
Not Applicable

  • Bandage scissors, reusable

Elite Stethoscope - 00816703023198

Elite Dual-Head Steth, Black, Elite First Aid Part Number: 601
MEDSOURCE INTERNATIONAL LLC
ELITE-70031
In Commercial Distribution

  • 00816703023204 ()
  • 00816703023198 ()
Not Applicable

  • Mechanical external stethoscope

Elite Bandage Strip - 00816703023099

Elite Bandage Strip, 1x3 / Elite First Aid Part Number: 560
MEDSOURCE INTERNATIONAL LLC
ELITE-17213
In Commercial Distribution

  • 00816703023105 ()
  • 00816703023099 ()
Not Applicable

  • Adhesive bandage

Elite Transparent Tape - 00816703023044

Elite, Transparent Tape, 1 / Elite First Aid Part Number: 4014
MEDSOURCE INTERNATIONAL LLC
ELITE-15010
In Commercial Distribution

  • 00816703023044 ()
  • 00816703023051 ()
Not Applicable

  • Dressing-fixation skin adhesive tape, non-silicone

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 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
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