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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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Omnigrip™ - 07332747078640

Omnigrip Screwdriver Machine 25mm
Nobel Biocare AB
37380
In Commercial Distribution

  • 07332747078640 ()

  • Length: 25.000 Millimeter
37380

  • Surgical screwdriver, reusable

Omnigrip™ - 07332747078633

Omnigrip Screwdriver Machine 30mm
Nobel Biocare AB
37381
In Commercial Distribution

  • 07332747078633 ()

  • Length: 30.000 Millimeter
37381

  • Surgical screwdriver, reusable

Omnigrip™ - 07332747078626

Omnigrip Screwdriver Machine 35mm
Nobel Biocare AB
37382
In Commercial Distribution

  • 07332747078626 ()

  • Length: 35.000 Millimeter
37382

  • Surgical screwdriver, reusable

NA - 07332747017434

Machine Screwdriver Slot Short
Nobel Biocare AB
DIA 188-0
In Commercial Distribution

  • 07332747017434 ()
DIA 188-0

  • Surgical screwdriver, reusable

NA - 07332747017427

Machine Screwdriver Slot Long
Nobel Biocare AB
DIA 189-0
In Commercial Distribution

  • 07332747017427 ()
DIA 189-0

  • Surgical screwdriver, reusable

NA - 07332747017410

Machine screwdriver hex long
Nobel Biocare AB
DIA 187-0
In Commercial Distribution

  • 07332747017410 ()
DIA 187-0

  • Surgical screwdriver, reusable

NA - 07332747007282

Handle for Machine Instruments
Nobel Biocare AB
29161
In Commercial Distribution

  • 07332747007282 ()
29161

  • Surgical screwdriver, reusable

Vive - 00810041981523

Replacement Ice Machine Pad
VIVE HEALTH LLC
RHB1049PAD
In Commercial Distribution

  • 10810041981520 ()
  • 00810041981523 ()


  • Hot/cold therapy pack, reusable

Vive - 00810113577517

Essential Ice Therapy Machine
VIVE HEALTH LLC
RHB3026BLK
In Commercial Distribution

  • 10810113577514 ()
  • 00810113577517 ()


  • Circulating-fluid localized thermal therapy system

On1™ - 07332747113877

On1 Screwdriver Machine 21mm
Nobel Biocare AB
38752
In Commercial Distribution

  • 07332747113877 ()

  • Length: 21.000 Millimeter
38752

  • Surgical screwdriver, reusable

Omnigrip™ - 07332747078657

Omnigrip Screwdriver Machine 20mm
Nobel Biocare AB
37379
In Commercial Distribution

  • 07332747078657 ()

  • Length: 20.000 Millimeter
37379

  • Surgical screwdriver, reusable

MICROTEK - 00748426009848

SLUSH MACHINE COVER, 1-EACH
Microtek Medical LLC
1
In Commercial Distribution

  • 50748426009843 ()
  • 30748426009849 ()
  • 00748426009848 ()


  • General-purpose bowl, single-use

Invivo - 00884838073234

Bone Biopsy Set, machine
Philips Ds North America LLC
98960320371
In Commercial Distribution

  • 00884838073234 ()


  • Manual surgical rotary handpiece, reusable

TTBio - 00810988030308

TTCare 100+ Maintenance Machine
HANDPIECE PARTS & REPAIRS, INC.
08090012TB4
In Commercial Distribution

  • 00810988030308 ()
08090012TB4

  • Dental handpiece maintenance unit

Hex Driver for Machine - 08806169139306

Hex Driver for Machine (DMDH12L)
DENTIS CO. ,LTD
DMDH12L
In Commercial Distribution

  • 08806169139306 ()


  • Surgical screwdriver, reusable

SNC Phantom (WL-QA) - 05060608880966

Radiation therapy, machine QA device
SUN NUCLEAR CORP.
1253300
In Commercial Distribution

  • 05060608880966 ()
1253300

  • Accelerator system quality assurance device

MultiMet-WL QA - 05060608880911

Radiation therapy, machine QA device
SUN NUCLEAR CORP.
1257000-0MR
In Commercial Distribution

  • 05060608880911 ()
1257000-0MR

  • Accelerator system quality assurance device

SNC Phantom (FS-QA) - 05060608880812

Radiation therapy, machine QA device
SUN NUCLEAR CORP.
1252300
In Commercial Distribution

  • 05060608880812 ()
1252300

  • Accelerator system quality assurance device

SNC Phantom (MV-QA) - 05060608880799

Radiation therapy, machine QA device
SUN NUCLEAR CORP.
1251500
In Commercial Distribution

  • 05060608880799 ()
1251500

  • Accelerator system quality assurance device

SNC Phantom (kV-QA) - 05060608880782

Radiation therapy, machine QA device
SUN NUCLEAR CORP.
1250300
In Commercial Distribution

  • 05060608880782 ()
1250300

  • Accelerator system quality assurance device

StereoPHAN - 05060608880102

Radiation therapy, machine QA device
SUN NUCLEAR CORP.
1255300
In Commercial Distribution

  • 05060608880102 ()
1255000-0Z

  • Accelerator system quality assurance device

Aerobiotix - 00852348007438

Air purification machine vac hose
AEROBIOTIX, INC.
AeroCure Vac Hose XL
In Commercial Distribution

  • 00852348007438 ()


  • Surgical laminar airflow unit

Trophy Skin - 00851561006006

Microderm MD Home Microdermabrasion Machine
TROPHY SKIN, INC
MicrodermMD
In Commercial Distribution

  • 00851561006006 ()


  • Dermabrasion brush, rotary

Venni / Biolight - 00852503007198

Venni / Biolight 12-channel EKG machine
VENNI INSTRUMENTS INC.
E80
In Commercial Distribution

  • 00852503007198 ()


  • Electrocardiograph, professional, multichannel

Venni / Biolight - 00852503007181

Venni / Biolight 12-channel EKG machine
VENNI INSTRUMENTS INC.
E70
In Commercial Distribution

  • 00852503007181 ()


  • Electrocardiograph, professional, multichannel

Venni / Biolight - 00852503007174

Venni / Biolight 3-channel EKG machine
VENNI INSTRUMENTS INC.
E30
In Commercial Distribution

  • 00852503007174 ()


  • Electrocardiograph, professional, multichannel

T2 STRATOSPHERE™ Expandable Corpectomy System - 00643169611801

MACHINE SCREW 4369003 3MM SLOTTED
MEDTRONIC SOFAMOR DANEK, INC.
4369003
In Commercial Distribution

  • 00643169611801 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable

T2 STRATOSPHERE™ Expandable Corpectomy System - 00643169611795

MACHINE SCREW 4369002 2MM SLOTTED
MEDTRONIC SOFAMOR DANEK, INC.
4369002
In Commercial Distribution

  • 00643169611795 ()


  • Surgical implant/trial-implant/sizer holder, reusable

Integra® - 10381780344759

BRS RET ARM VISE MACHINE
INTEGRA LIFESCIENCES CORPORATION
417A2005
In Commercial Distribution

  • 10381780344759 ()
417A2005

  • Neurosurgical retraction system, brain

MEDIDENTA - 00810988030346

MEDIDENTA iCLEAN HANDPIECE MAINTENANCE MACHINE
HANDPIECE PARTS & REPAIRS, INC.
MEDI-012PL1
In Commercial Distribution

  • 00810988030346 ()
MEDI-012PL1

  • Dental handpiece maintenance unit

X-CEL X-RAY CORPORATION - B216P700MAC1

PODIATRY X-RAY MACHINE, 15mA, 50-70kV
ARQUILLA, INC.
P700M A/C
In Commercial Distribution

  • B216P700MAC1 ()


  • Stationary basic diagnostic x-ray system, analogue

X-CEL X-RAY CORPORATION - B216MB715NT1

PODIATRY X-RAY MACHINE, 15mA, 50-70kV
ARQUILLA, INC.
MB-715NT
In Commercial Distribution

  • B216MB715NT1 ()


  • Stationary basic diagnostic x-ray system, analogue

X-CEL X-RAY CORPORATION - B216LB715NT1

PODIATRY X-RAY MACHINE, 15mA, 50-70kV
ARQUILLA, INC.
LB-715NT
In Commercial Distribution

  • B216LB715NT1 ()


  • Stationary basic diagnostic x-ray system, analogue

X-CEL X-RAY CORPORATION - B216FB910A40K1

PODIATRY X-RAY MACHINE, 10mA, 50-90kV
ARQUILLA, INC.
FB910A-40K
In Commercial Distribution

  • B216FB910A40K1 ()


  • Stationary basic diagnostic x-ray system, analogue

X-CEL X-RAY CORPORATION - B216FB715NT1

PODIATRY X-RAY MACHINE, 15mA, 50-70kV
ARQUILLA, INC.
FB-715NT
In Commercial Distribution

  • B216FB715NT1 ()


  • Stationary basic diagnostic x-ray system, analogue

X-CEL X-RAY CORPORATION - B216BDXC7001

PODIATRY X-RAY MACHINE, 15mA, 50-70kV
ARQUILLA, INC.
BDXC-700
In Commercial Distribution

  • B216BDXC7001 ()


  • Stationary basic diagnostic x-ray system, analogue

X-CEL X-RAY CORPORATION - B216715TBD1

PODIATRY X-RAY MACHINE, 15mA, 50-70kV
ARQUILLA, INC.
715T-BD
In Commercial Distribution

  • B216715TBD1 ()


  • Stationary basic diagnostic x-ray system, analogue

X-CEL X-RAY CORPORATION - B216715SD1

PODIATRY X-RAY MACHINE, 15mA, 50-70kV
ARQUILLA, INC.
715-SD
In Commercial Distribution

  • B216715SD1 ()


  • Stationary basic diagnostic x-ray system, analogue

X-CEL X-RAY CORPORATION - B216715RSD1

PODIATRY X-RAY MACHINE, 15mA, 50-70kV
ARQUILLA, INC.
715R-SD
In Commercial Distribution

  • B216715RSD1 ()


  • Stationary basic diagnostic x-ray system, analogue

X-CEL X-RAY CORPORATION - B216715BBD1

PODIATRY X-RAY MACHINE, 15mA, 50-70kV
ARQUILLA, INC.
715B-BD
In Commercial Distribution

  • B216715BBD1 ()


  • Stationary basic diagnostic x-ray system, analogue

Medline-Microtek - 00748426141104

Hush Slush Surgical Slush Machine
Microtek Medical LLC
Surgical Slush - Hush-Slush Equipment
In Commercial Distribution

  • 00748426141104 ()
ORS-1075HS-42

  • Ice maker/dispenser

Medline-Microtek - 00748426140695

Hush Slush Surgical Slush Machine
Microtek Medical LLC
Surgical Slush - Hush-Slush Equipment
In Commercial Distribution

  • 00748426140695 ()
ORS-1075HS

  • Ice maker/dispenser

Vive - 00810041987617

Replacement Ice Machine Pad Ankle
VIVE HEALTH LLC
RHB1049RPA
In Commercial Distribution

  • 10810041987614 ()
  • 00810041987617 ()


  • Circulating-fluid localized thermal therapy system pack, reusable

Vive - 00810041988157

Replacement Ice Machine Pad Hip
VIVE HEALTH LLC
RHB1049RPH
In Commercial Distribution

  • 10810041988154 ()
  • 00810041988157 ()


  • Circulating-fluid localized thermal therapy system pack, reusable

Vive - 00810041988140

Replacement Ice Machine Pad Shoulder
VIVE HEALTH LLC
RHB1049RPS
In Commercial Distribution

  • 10810041988147 ()
  • 00810041988140 ()


  • Circulating-fluid localized thermal therapy system pack, reusable

Vive - 00810041988133

Replacement Ice Machine Pad Knee
VIVE HEALTH LLC
RHB1049RPK
In Commercial Distribution

  • 10810041988130 ()
  • 00810041988133 ()


  • Circulating-fluid localized thermal therapy system pack, reusable

Vive - 00810041988126

Replacement Ice Machine Pad Ankle
VIVE HEALTH LLC
RHB1049RPA
Not in Commercial Distribution

  • 10810041988123 ()
  • 00810041988126 ()


  • Circulating-fluid localized thermal therapy system pack, reusable

Shenzhen Wells Optoelectronics Co.,Ltd. - 06977182819390

Multifunction Body Massager Machine/939
Shenzhen Wells Optoelectronics Co.,Ltd.
939
In Commercial Distribution

  • 06977182819390 ()


  • Hand-held electric massager

Shenzhen Wells Optoelectronics Co.,Ltd. - 06977182819192

Multifunction Body Massager Machine/919AS
Shenzhen Wells Optoelectronics Co.,Ltd.
919AS
In Commercial Distribution

  • 06977182819192 ()


  • Hand-held electric massager

Shenzhen Wells Optoelectronics Co.,Ltd. - 06977182810014

Multifunction Body Massager Machine/DZ-01
Shenzhen Wells Optoelectronics Co.,Ltd.
DZ-01
In Commercial Distribution

  • 06977182810014 ()


  • Hand-held electric massager
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