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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No Description
Safetyfix Medical Technologies
2.0MM CANNULATED SCREW, SQUARE DRIVER, 1.9MM HEAD, LENGTH 14
In Commercial Distribution

  • 00853785008064 ()

  • Length: 14 Millimeter
  • Outer Diameter: 2.0 Millimeter
22761-0003-1.9-14

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
2.0MM CANNULATED SCREW, SQUARE DRIVER, 1.9MM HEAD, LENGTH 12
Safetyfix Medical Technologies
2.0MM CANNULATED SCREW, SQUARE DRIVER, 1.9MM HEAD, LENGTH 12
In Commercial Distribution

  • 00853785008057 ()

  • Length: 12 Millimeter
  • Outer Diameter: 2.0 Millimeter
22761-0003-1.9-12

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Screw Driver for Bone Screws
Safetyfix Medical Technologies
Driver
In Commercial Distribution

  • 00853785008040 ()
Driver

  • Surgical screwdriver, reusable
CONTAINER 9735231 LEGACY TAPS / DRIVERS
Case Medical Inc.
9735231
In Commercial Distribution

  • 00653159011795 ()
9735231

  • Device sterilization/disinfection container, reusable
CONTAINER 9735218 SOLERA 5.5/6.0 DRIVER
Case Medical Inc.
9735218
In Commercial Distribution

  • 00653159011764 ()
9735218

  • Device sterilization/disinfection container, reusable
CONTAINER 9734863 SOLERA TAPS DRIVERS
Case Medical Inc.
9734863
In Commercial Distribution

  • 00653159011733 ()
9734863

  • Device sterilization/disinfection container, reusable
CONTAINER LEGACY™ TAPS/DRIVERS
Case Medical Inc.
9735231
In Commercial Distribution

  • 00653159010545 ()
9735231

  • Device sterilization/disinfection container, reusable
CONTAINER SOLERA™ 5.5/6.0 DRIVER
Case Medical Inc.
9735218
In Commercial Distribution

  • 00653159010514 ()
9735218

  • Device sterilization/disinfection container, reusable
CONTAINER SOLERA™ TAPS DRIVERS
Case Medical Inc.
9734863
In Commercial Distribution

  • 00653159010491 ()
9734863

  • Device sterilization/disinfection container, reusable
CONTAINER LEGACY™ TAPS/DRIVERS
Case Medical Inc.
9735231
In Commercial Distribution

  • 00653159008719 ()
9735231

  • Device sterilization/disinfection container, reusable
CONTAINER SOLERA™ 5.5/6.0 DRIVER
Case Medical Inc.
9735218
In Commercial Distribution

  • 00653159008689 ()
9735218

  • Device sterilization/disinfection container, reusable
CONTAINER SOLERA™ TAPS DRIVERS
Case Medical Inc.
9734863
In Commercial Distribution

  • 00653159008658 ()
9734863

  • Device sterilization/disinfection container, reusable
CONTAINER LEGACY™ TAPS DRIVERS
Case Medical Inc.
9734443
In Commercial Distribution

  • 00653159008559 ()
9734443

  • Device sterilization/disinfection container, reusable
CONTAINER LEGACY™ TAPS/DRIVERS
Case Medical Inc.
9735231
In Commercial Distribution

  • 00653159007422 ()
9735231

  • Device sterilization/disinfection container, reusable
CONTAINER SOLERA™ 5.5/6.0 DRIVER
Case Medical Inc.
9735218
In Commercial Distribution

  • 00653159007392 ()
9735218

  • Device sterilization/disinfection container, reusable
CONTAINER SOLERA™ TAPS DRIVERS
Case Medical Inc.
9734863
In Commercial Distribution

  • 00653159007361 ()
9734863

  • Device sterilization/disinfection container, reusable
CONTAINER SOLERA™ TAPS DRIVERS
Case Medical Inc.
9734444
In Commercial Distribution

  • 00653159007279 ()
9734444

  • Device sterilization/disinfection container, reusable
CONTAINER LEGACY™ TAPS DRIVERS
Case Medical Inc.
9734443
In Commercial Distribution

  • 00653159007262 ()
9734443

  • Device sterilization/disinfection container, reusable
The Universal SmartECG is an ECG amplifier that connects to electrodes on a patient and a PC with Windows operating systems via a USB connection. The ECG amplifier detects electrical impulses from the patient and coverts them into a digital signal that can be displayed and recorded on the computer. The ECG system consists of a 12-lead ECG, multi-language Office Medic Software and VectraplexECG, a UL 60950 compliant host computer and accessories. The 12-lead ECG includes an analog front end designed to detect, amplify, filter, and output biopotential measurements in real time, a microprocessor to communicate and control the analog front end and system, short circuit protection, ESD protection, defibrillation isolation and protection, a green indication LED, 10 leadwires, lead off detection, USB communication to PC and Office Medic or VectraplexECG, and bootloader. The device is powered by the USB connector and is regulated to two separate supplies, a 3.3V digital supply and a 3.3V analog supply to respectively power the digital and analog circuitry. The 12-lead ECG outputs ECG waveform information via USB to the Office Medic or VectraplexECG Software that translates, filters, analyzes, and displays the ECG waveform in real time. The hardware contains an FTDI USB UART translator chip to install required USB drivers to the PC and allow appropriate data conversion to the PC during ECG measurement.
VECTRACOR INC
AHA
In Commercial Distribution

  • 00857175006173 ()
Z-7000-0500

  • Electrocardiograph, professional, multichannel
The H&H Situational Instrument Tray (SIT) Kit is a sterile, single use kit for performing many surgical procedures immediately. The SIT Kit provides a generic set of must-have instruments in a convenient vacuum-sealed bag ready for use. The SIT kit contains: A 5.5" Straight Crile Hemostat A 4.5" Straight Iris Scissors A 9.75" Medium Magill Forceps A 6" Mayo-Hegar needle driver, and A protective sterile field wrap
H&H MEDICAL CORPORATION
1
In Commercial Distribution

  • 00857048006057 ()
HHSIT01

  • General surgical procedure kit, non-medicated, single-use
2.0mm x 229mm K-wire
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
WIR2-229
In Commercial Distribution

  • 00856719002237 ()

  • tool/instrument
WIR2-229

  • Manual wire driver
Guidewire Driver
Si-Bone Inc.
501323
In Commercial Distribution

  • 00855369008705 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit
Torx Driver
Si-Bone Inc.
501243
In Commercial Distribution

  • 00855369008699 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit
Nav Adapter - Driver
Si-Bone Inc.
400291
In Commercial Distribution

  • 00855369008682 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit
Driver Sleeve 1
Si-Bone Inc.
400248
In Commercial Distribution

  • 00855369008521 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit
Driver Sleeve 2
Si-Bone Inc.
400262
In Commercial Distribution

  • 00855369008514 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit
Torx Driver, Cannulated
Si-Bone Inc.
501129
In Commercial Distribution

  • 00855369008484 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit
SubQ It! Bioabsorbable Driver SU-10 is a single-patient use, skin closure device, preloaded with 10 bioabsorbable dermal fasteners, packaged sterile in a protective foil pouch.
OPUS KSD, INC.
SU-10
In Commercial Distribution

  • 10867469000234 ()
  • 00867469000237 ()
412010

  • Skin stapler/staple, bioabsorbable
SubQ It! Bioabsorbable Driver SU-10 is a single-patient use, skin closure device, preloaded with 10 bioabsorbable dermal fasteners, packaged sterile in a protective foil pouch.
OPUS KSD, INC.
SU-10
In Commercial Distribution

  • 10867469000227 ()
  • 00867469000220 ()
412010

  • Skin stapler/staple, bioabsorbable
ORTHOGNATHIC, SURGICAL PLANNING KIT W/ 3D PRINTED TITANIUM PLATES AND TITANIUM HYBRID GUIDES, SINGLE JAW
Medcad
MC-KTP010-H
In Commercial Distribution

  • 00864582000298 ()
MC-KTP010-H

  • Dental milling system, CAD/CAM, laboratory
  • Custom-made organ/bone anatomy model/surgical guide kit
  • Craniofacial fixation plate, non-bioabsorbable, non-customized
ORTHOGNATHIC, SURGICAL PLANNING KIT W/ 3D PRINTED TITANIUM PLATES AND TITANIUM GUIDES, SINGLE JAW
Medcad
MC-KTP010
In Commercial Distribution

  • 00864582000281 ()
MC-KTP010

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
  • Custom-made organ/bone anatomy model/surgical guide kit
  • Dental milling system, CAD/CAM, laboratory
ORTHOGNATHIC, SURGICAL PLANNING KIT W/ 3D PRINTED TITANIUM PLATES AND TITANIUM HYBRID GUIDES
Medcad
MC-KTP000-H
In Commercial Distribution

  • 00864582000274 ()
MC-KTP000-H

  • Dental milling system, CAD/CAM, laboratory
  • Custom-made organ/bone anatomy model/surgical guide kit
  • Craniofacial fixation plate, non-bioabsorbable, non-customized
AdvantageRib X-Driver, AO Quick-Connect
SIG MEDICAL CORP.
323.0075
In Commercial Distribution

  • 00854865007403 ()
323.0075

  • Surgical screwdriver, reusable
Slap Hammer
DECIMA SPINE, INC.
6120
In Commercial Distribution

  • 00857360007107 ()
6120

  • Surgical mallet
REMOVAL DRIVER
DECIMA SPINE, INC.
6096
In Commercial Distribution

  • 00857360007077 ()
6096

  • Surgical screwdriver, reusable
Driver
DECIMA SPINE, INC.
6094
In Commercial Distribution

  • 00857360007053 ()
6094

  • Surgical screwdriver, reusable
No Description
Moximed, Inc.
1-4039
In Commercial Distribution

  • 00856047005917 ()


  • Orthopaedic surgical procedure kit, non-medicated, single-use
The Explant Kit package contains 2 Lead Caps and 1 Torque Driver.
Neuropace, Inc.
EX-01-K
In Commercial Distribution

  • 00855547005410 ()


  • Brain-responsive electrical stimulation system
The Connector Cover package contains 1 Connector Cover, 2 Connector Plugs, 1 Lead Strain Relief and 1 Torque Driver.
Neuropace, Inc.
CC-01-K
In Commercial Distribution

  • 00855547005397 ()


  • Brain-responsive electrical stimulation system
The Craniectomy Template package contains 1 Craniectomy Template, 1 Lead Strain Relief and 1 Torque Driver.
Neuropace, Inc.
CT-01-K
In Commercial Distribution

  • 00855547005380 ()


  • Brain-responsive electrical stimulation system
The Ferrule package contains 1 Ferrule, 1 Ferrule Clamp and 1 Torque Driver.
Neuropace, Inc.
F-01-K
In Commercial Distribution

  • 00855547005373 ()


  • Brain-responsive electrical stimulation system
The NeuroPace® RNS® Neurostimulator package contains 1 RNS® Neurostimulator, 1 Connector Cover, 1 Ferrule, 1 Ferrule Clamp, 1 Lead Strain Relief and 1 Torque Driver.
Neuropace, Inc.
RNS-320-K
In Commercial Distribution

  • 00855547005366 ()


  • Brain-responsive electrical stimulation system
The NeuroPace® RNS® Neurostimulator package contains 1 RNS® Neurostimulator, 1 Connector Cover, 1 Ferrule, 1 Ferrule Clamp, 1 Lead Strain Relief and 1 Torque Driver.
Neuropace, Inc.
RNS-320-K
In Commercial Distribution

  • 00855547005267 ()


  • Brain-responsive electrical stimulation system
The Burr Hole Cover package contains 1 Burr Hole Cover.
Neuropace, Inc.
8110
In Commercial Distribution

  • 00855547005205 ()

  • Compatible with a 1.3 mm lead. Requires three 1.5 to 1.8 mm bone screws.
  • Outer Diameter: 14 Millimeter


  • Cranial bur hole cover
  • Craniofacial fixation plate, non-bioabsorbable, non-customized
The Ferrule package contains 1 Ferrule, 1 Ferrule Clamp and 1 Torque Driver.
Neuropace, Inc.
F-01-K
In Commercial Distribution

  • 00855547005175 ()


  • Brain-responsive electrical stimulation system
The Craniectomy Template package contains 1 Craniectomy Template, 1 Lead Strain Relief and 1 Torque Driver.
Neuropace, Inc.
CT-01-K
In Commercial Distribution

  • 00855547005168 ()


  • Brain-responsive electrical stimulation system
The Connector Cover package contains 1 Connector Cover, 2 Connector Plugs, 1 Lead Strain Relief and 1 Torque Driver.
Neuropace, Inc.
CC-01-K
In Commercial Distribution

  • 00855547005151 ()


  • Brain-responsive electrical stimulation system
The NeuroPace® RNS® Neurostimulator package contains 1 RNS® Neurostimulator, 1 Connector Cover, 1 Ferrule, 1 Ferrule Clamp, 1 Lead Strain Relief and 1 Torque Driver.
Neuropace, Inc.
RNS-300M-K
In Commercial Distribution

  • 00855547005120 ()


  • Brain-responsive electrical stimulation system
Slotted 90° Tubular Wrench x 10mm
Metalogix
900104
In Commercial Distribution

  • 00854641008112 ()

  • Slotted 90°
  • Diameter: 10mm
  • Length: 3.89 Inch


  • External orthopaedic fixation system, reusable
General Tray
Metalogix
900127-F
In Commercial Distribution

  • 00854641008099 ()

  • Height: 10.1 Inch
  • Length: 20.9 Inch
  • Width: 10.3 Inch


  • External orthopaedic fixation system, reusable
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