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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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TECHFIT - 00860007543449

Intermediate Orhognathic Surgical Splint
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860007543449 ()
FICOBC

  • Custom-made orthopaedic/craniofacial surgical guide

Insurgical, Inc. - 00860007230066

2.0 - 3.2 Pin Driver Assembly
Insurgical, Inc.
320-0070-001
In Commercial Distribution

  • 00860007230066 ()
9250022

  • Pin-driving power tool attachment

Insurgical, Inc. - 00860007230059

3.2 - 4.0 Pin Driver Assembly
Insurgical, Inc.
320-0107-001
In Commercial Distribution

  • 00860007230059 ()
9250023

  • Pin-driving power tool attachment

MIS Precision Chevron Bunion System - 00860005968800

The MIS Precision Chevron Bunion System™ is a kit designed to allow surgeons to perform a chevron bunion osteotomy, and subsequent fixation of the osteotomy, with a minimally invasive surgical technique. The MIS Precision Chevron Bunion System™ consists of a single, sterile-packaged SKU that contains both implants and instruments needed for the procedure. The implants in the kit are cannulated headless compression screws, made from titanium (Ti-6AL-4V ELI). There are two implants in the kit, however only one is used in a surgical procedure. Two implants are provided to allow the physician to select the proper size for the patient at the time of surgery. The implants are 3.5 mm diameter, with lengths of 24 mm and 27 mm. There are also single-use instruments, made of injection molded polycarbonate, PEEK, and stainless steel included in the MIS Precision Chevron Bunion System™. Instruments include an osteotomy guide (one each for left and right feet), a targeting guide, a screw guide, screwdriver, drill bit, and several K-wires and a guidewire. Additional general surgical instrumentation is utilized, but not part of the RELJA system, such as sagittal saw, drivers, and scalpel.
Relja Innovations LLC
RI-2427-C
In Commercial Distribution

  • 00860005968800 ()


  • Orthopaedic bone screw, non-bioabsorbable, sterile

EasyShift - 00860004936817

EasyShift Repositioning System V3 for 42" wide mattress, compatible with EasyShift Zipper Sheet
Seneca Devices, Inc.
EAS-42-Z
In Commercial Distribution

  • 00860004936817 ()


  • Bed mattress support platform, hydraulic
  • Intensive-care patient transport system, ventilatory support, neonatal

Santastic Infrared Forehead Thermometer - 00860004330691

No Description
BUY SUPPLY INC
PG-IRT1602
In Commercial Distribution

  • 00860004330691 ()


  • Infrared patient thermometer, ear

AXIUS 8mm Needle Driver - Long - 00860004002147

No Description
FlexDex Surgical
8ND1L
In Commercial Distribution

  • 00860004002147 ()


  • Suturing needle holder, reusable

AXIUS 8mm Needle Driver - Medium - 00860004002130

No Description
FlexDex Surgical
8ND1M
In Commercial Distribution

  • 00860004002130 ()


  • Suturing needle holder, reusable

FlexDex Needle Driver - 00860004002109

No Description
FlexDex Surgical
FD-335 ND
Not in Commercial Distribution

  • 00860004002116 ()
  • 00860004002109 ()


  • Suturing needle holder, single-use

Abiomed Breethe OXY-1 System - 00860001797947

Pump Driver Service Replacement Kit
Breethe, Inc.
001-0301-003
In Commercial Distribution

  • 00860001797947 ()
001-0301-003

  • Cardiopulmonary bypass system, non-roller type

MIRARI Cold Plasma Driver - 00860013508616

No Description
General Vibronics, LLC
GVM2
In Commercial Distribution

  • 00860013508616 ()


  • Medium-wave diathermy treatment system generator

TECHFIT - 00860012759460

Maxilla Cutting Guide Ti
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860012759460 ()
GCMAXTI

  • Custom-made orthopaedic/craniofacial surgical guide

TECHFIT - 00860012759453

Mandible Cutting Guide Ti
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860012759453 ()
GCMANTI

  • Custom-made orthopaedic/craniofacial surgical guide

TECHFIT - 00860012759446

Fibula cutting guide Ti
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860012759446 ()
GCPTI

  • Custom-made orthopaedic/craniofacial surgical guide

TECHFIT - 00860012759422

Palatal Orthog Surgical Splint Digital
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860012759422 ()
FPCOD

  • Custom-made orthopaedic/craniofacial surgical guide

TECHFIT - 00860012759415

Interm Orthog Surgical Splint Digital
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860012759415 ()
FICOD

  • Custom-made orthopaedic/craniofacial surgical guide

TECHFIT - 00860012759408

Final Orthog Surgical Splint Digital
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860012759408 ()
FFCOD

  • Custom-made orthopaedic/craniofacial surgical guide

TECHFIT - 00860011469285

Condyle Position Guide - Ti
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860011469285 ()
CGPTI

  • Custom-made orthopaedic/craniofacial surgical guide

TECHFIT - 00860011469278

Guide anchor screws with dental support Ti
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860011469278 ()
GASDSTI

  • Custom-made orthopaedic/craniofacial surgical guide

TECHFIT - 00860011469261

BSSO Surgical Guide with Dental Support - TI
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860011469261 ()
GCSDTI

  • Custom-made orthopaedic/craniofacial surgical guide

TECHFIT - 00860011469230

BSSO Surgical Guide - TI
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860011469230 ()
GCSTI

  • Custom-made orthopaedic/craniofacial surgical guide

TECHFIT - 00860011469223

Palatal Orthognathic Surgical Splint - Resin
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860011469223 ()
FPCOBC

  • Custom-made orthopaedic/craniofacial surgical guide

TECHFIT - 00860011469216

Palatal Orthognathic Surgical Splint - TI
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860011469216 ()
FPCOTI

  • Custom-made orthopaedic/craniofacial surgical guide

TECHFIT - 00860010801680

Screw metal sleeve
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860010801680 ()
Q-SPTS

  • Custom-made orthopaedic/craniofacial surgical guide

TECHFIT - 00860010801673

Slot metal sleeve
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860010801673 ()
Q-SPCS

  • Custom-made orthopaedic/craniofacial surgical guide

TECHFIT - 00860010801666

Drill metal sleeve
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860010801666 ()
Q-SPBS

  • Custom-made orthopaedic/craniofacial surgical guide

TECHFIT - 00860010801659

Genioplasty Surgical Guide - Ti
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860010801659 ()
GCGTI

  • Custom-made orthopaedic/craniofacial surgical guide

TECHFIT - 00860010801642

Genioplasty Surgical Guide with dental support - Ti
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860010801642 ()
GCGSDTI

  • Custom-made orthopaedic/craniofacial surgical guide

TECHFIT - 00860010801635

Le Fort Surgical Guide - Ti
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860010801635 ()
GCLTI

  • Custom-made orthopaedic/craniofacial surgical guide

TECHFIT - 00860010801628

Le Fort Surgical Guide with dental support - TI
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860010801628 ()
GCLSDTI

  • Custom-made orthopaedic/craniofacial surgical guide

TECHFIT - 00860010801611

Genioplasty Surgical Guide with Splint - Resin
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860010801611 ()
GCGFBC

  • Custom-made orthopaedic/craniofacial surgical guide

TECHFIT - 00860010801604

Genioplasty Surgical Guide - Resin
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860010801604 ()
GCGBC

  • Custom-made orthopaedic/craniofacial surgical guide

EmbedMed - 00860009815735

Patient-specific, Maxillofacial Anatomical Model, Digital
3D LIFEPRINTS UK LTD
CMFDAM
Not in Commercial Distribution

  • 00860009815735 ()


  • Custom-made organ/bone anatomy model

EmbedMed - 00860009815728

Patient-specific, Maxillofacial Surgical Guide
3D LIFEPRINTS UK LTD
CMFSG
In Commercial Distribution

  • 00860009815728 ()


  • Custom-made orthopaedic/craniofacial surgical guide

EmbedMed - 00860009815711

Patient-specific, Maxillofacial Anatomical Model, For End-user Sterilization
3D LIFEPRINTS UK LTD
CMFAMFEUS
In Commercial Distribution

  • 00860009815711 ()


  • Custom-made organ/bone anatomy model

EmbedMed - 00860009815704

Patient-specific, Maxillofacial Anatomical Model, Non-sterile
3D LIFEPRINTS UK LTD
CMFAMNS
In Commercial Distribution

  • 00860009815704 ()


  • Custom-made organ/bone anatomy model

Decima Spine Instrument Kit - 00857360007107

Slap Hammer
DECIMA SPINE, INC.
6120
In Commercial Distribution

  • 00857360007107 ()
6120

  • Surgical mallet

Decima Spine Instrument Kit - 00857360007077

REMOVAL DRIVER
DECIMA SPINE, INC.
6096
In Commercial Distribution

  • 00857360007077 ()
6096

  • Surgical screwdriver, reusable

Decima Spine Instrument Kit - 00857360007053

Driver
DECIMA SPINE, INC.
6094
In Commercial Distribution

  • 00857360007053 ()
6094

  • Surgical screwdriver, reusable

Universal SmartECG - 00857175006173

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
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