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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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HU-FRIEDY - 10889950046934

UNC38/39-0 DE EXCAVATOR
HU-FRIEDY MFG. CO., LLC
ECO1322
In Commercial Distribution

  • 10889950046934 ()
ECO1322

  • Dental excavator, reusable

HU-FRIEDY - 10889950046927

#60/61 MARQUETTE DE EXCAVATOR
HU-FRIEDY MFG. CO., LLC
ECO1321
Not in Commercial Distribution

  • 10889950046927 ()
ECO1321

  • Dental excavator, reusable

HU-FRIEDY - 10889950046910

#72/73 MARQUETTE DE EXCAVATOR
HU-FRIEDY MFG. CO., LLC
ECO1320
In Commercial Distribution

  • 10889950046910 ()
ECO1320

  • Dental excavator, reusable

HU-FRIEDY - 10889950046903

42/43 DE OPERATIVE EXCAVATOR
HU-FRIEDY MFG. CO., LLC
ECO1319
Not in Commercial Distribution

  • 10889950046903 ()
ECO1319

  • Dental excavator, reusable

HU-FRIEDY - 10889950046897

#78/79 DE EXCAVATOR
HU-FRIEDY MFG. CO., LLC
ECO1317
Not in Commercial Distribution

  • 10889950046897 ()
ECO1317

  • Dental excavator, reusable

HU-FRIEDY - 10889950046880

#78/79 MARQUETTE DE EXCAVATOR
HU-FRIEDY MFG. CO., LLC
ECO1316
Not in Commercial Distribution

  • 10889950046880 ()
ECO1316

  • Dental excavator, reusable

HU-FRIEDY - 10889950046873

DE Endo Excavator 31W
HU-FRIEDY MFG. CO., LLC
ECE7073K
In Commercial Distribution

  • 10889950046873 ()
ECE7073K

  • Dental excavator, reusable

HU-FRIEDY - 10889950046866

#33L DE Endo Excavator w/#7 hdl.
HU-FRIEDY MFG. CO., LLC
ECE56327C
In Commercial Distribution

  • 10889950046866 ()
ECE56327C

  • Dental excavator, reusable

HU-FRIEDY - 10889950046859

#2 Glick DE Endo Exca Satin Steel Hdl
HU-FRIEDY MFG. CO., LLC
ECE5611
In Commercial Distribution

  • 10889950046859 ()
ECE5611

  • Dental excavator, reusable

HU-FRIEDY - 10889950046842

#40/41 Exca (11-7-14) Satin Steel Hdl
HU-FRIEDY MFG. CO., LLC
ECE5601
In Commercial Distribution

  • 10889950046842 ()
ECE5601

  • Dental excavator, reusable

StatPACS - 00860257001102

StatPACS is a software based PACS product, intended to be used by radiologists, technologists and clinicians to operate on specified off the shelf hardware that will provide a teleradiology and PACS solution for hospitals/clinics and remote site use. The StatPACS software will transmit, receive, display, and store 2D/3D images for clinical evaluation and diagnosis.
NUCLEUSHEALTH, LLC
1000
In Commercial Distribution

  • 00860257001102 ()


  • Diagnostic imaging telemedicine system

Kohli Catheter - 00860239001304

Kohli Urinary Drainage Catheter, 16 Fr, Silicone
NELLIE MEDICAL, LLC
20-100
In Commercial Distribution

  • 00860239001328 ()
  • 00860239001311 ()
  • 00860239001304 ()

  • Catheter Length: 440 Millimeter
  • Catheter Gauge: 16 French
20-100

  • Indwelling urethral drainage balloon catheter, non-antimicrobial

illuvinate System - 00860228002107

No Description
LUMA THERAPEUTICS, INC.
CAT0581
In Commercial Distribution

  • 00860228002107 ()


  • Light-energy skin surface treatment system applicator

KetoBM - 00860182000645

Ketone Test Strips - 40 pack
Ketobm LLC
KS-01
In Commercial Distribution

  • 00860182000645 ()


  • Ketone (acetoacetate) IVD, reagent

FUSION-DOE Light System - 00860179001075

FUSION-DOE Light System
Dentlight Inc.
7700512
In Commercial Distribution

  • 00860179001075 ()
7700512

  • Oral lesion examination light

System 83 Revolve - 00860010835241

The System 83 Revolve® Endoscope Washer/Disinfector is an automated, computer controlled, electro-mechanical system intended to wash and high-level disinfect one or two submersible flexible endoscopes utilizing a detergent and FDA cleared high-level disinfectant validated by Wassenburg Medical. The System 83 Revolve® utilizes a processing chamber and the immersion method to perform washing, disinfection, rinsing, and alcohol flush of an endoscope to render a high-level disinfected endoscope. The System 83 Revolve® is capable of automated detergent dispensing and transfer of disinfectant solution between the reservoir and processing chamber. Following disinfection, the endoscopes and channels are automatically rinsed with potable water that is filtered through a water filtration system that contains a 0.1 micron bacteria filter and the channels are then flushed with air. A semi-automated air/alcohol flush must be completed at the end of the cycle. At completion, the operator prints out the endoscope reprocess
Wassenburg Medical, Inc.
System 83 Revolve
In Commercial Distribution

  • 00860010835241 ()


  • Endoscope washer-disinfector (chemical)

TECHFIT - 00860010801697

Mandible And Maxilla Model - 2 Piece
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860010801697 ()
MAPMANI2P

  • Custom-made organ/bone anatomy model

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

Amron Oxygen Treatment Hood - 00860010778616

02 VINYL HOOD W/OPTICAL WINDOW, NECK RING ASSEMBLY, UNTRIMMED SILICONE NECK SEAL
Amron International, Inc.
8891-03
In Commercial Distribution

  • 00860010778616 ()


  • Oxygen administration hood, adult

Amron Oxygen Treatment Hood - 00860010778609

02 VINYL HOOD W/OPTICAL WINDOW, NECK RING ASSEMBLY, STRAPS AND UNTRIMMED SILICONE NECK SEAL
Amron International, Inc.
8891-03S
In Commercial Distribution

  • 00860010778609 ()


  • Oxygen administration hood, adult

PPS Glide - 00860010693155

No Description
PATIENT POSITIONING SYSTEMS, LLC
SPU Bariatric
In Commercial Distribution

  • 00860010693155 ()


  • Inflatable patient transfer sliding mattress, single-use

PPS Glide - 00860010693148

No Description
PATIENT POSITIONING SYSTEMS, LLC
SPU Large
In Commercial Distribution

  • 00860010693148 ()


  • Inflatable patient transfer sliding mattress, single-use

PPS Glide - 00860010693131

Regular
PATIENT POSITIONING SYSTEMS, LLC
SPU Regular
In Commercial Distribution

  • 00860010693131 ()


  • Inflatable patient transfer sliding mattress, single-use

PPS Glide - 00860010693124

No Description
PATIENT POSITIONING SYSTEMS, LLC
Reusable Bariatric
In Commercial Distribution

  • 00860010693124 ()


  • Inflatable patient transfer sliding mattress, reusable

PPS Glide - 00860010693117

No Description
PATIENT POSITIONING SYSTEMS, LLC
Reusable Large
In Commercial Distribution

  • 00860010693117 ()


  • Inflatable patient transfer sliding mattress, reusable

PPS Glide - 00860010693100

Regular
PATIENT POSITIONING SYSTEMS, LLC
Reusable Regular
In Commercial Distribution

  • 00860010693100 ()


  • Inflatable patient transfer sliding mattress, reusable

Torch - 00860010685402

No Description
Voximetry, Inc.
V1.2
In Commercial Distribution

  • 00860010685402 ()


  • Nuclear medicine system workstation

Corix 70 - 00860010674406

Sistema diagnóstico de rayos X dental diseñado para fijación permanente en una ubicación con objeto de generar y controlar los haces de rayos X. Registra el patrón de absorción de los haces de rayos X utilizado para exámenes radiográficos dentales generales y rutinarios que implican el diagnóstico y tratamiento (p. ej., quirúrgico o intervencionista) de afecciones de las piezas dentales, mandíbula y cavidad bucal. El sensor se coloca fuera de la boca, con el propósito de visualizar toda el área de esta y mostrar las piezas dentales, tanto en la mandíbula superior como en la inferior. Los datos proceden de imágenes analógicas y que se digitalizan posteriormente o bien de imágenes digitales.
Coramex, S.A.
Corix 70 Plus USV
In Commercial Distribution

  • 00860010674406 ()


  • Stationary extraoral dental x-ray system, analogue

Fundus Photo - 00860010658109

Fundus Photo Digital Imaging System including hardware and/or software
Fundus Photo
CFD-440
In Commercial Distribution

  • 00860010658109 ()
CFD-440

  • Ophthalmic image analysis software
  • Multi-purpose digital medical camera lens, intraocular, visible/infrared light

Test-mate ChE Cholinesterase Test System - 00860010612200

For the quantitative determination of Cholinesterase in whole blood to monitor pesticide exposure. For in vitro diagnostic use. For laboratory use by trained laboratory technicians only. For use only with the AChE Assay Kit (Model 460) and the PChE Assay Kit (Model 470).
Eqm Research, Inc.
400
In Commercial Distribution

  • 00860010612200 ()
400

  • Acetylcholinesterase IVD, kit, spectrophotometry
  • Photometer, absorbance/transmission, automated

DiaDoc - 00860010611227

No Description
INSULIFE LLC
31G 1cc 8mm
In Commercial Distribution

  • 10860010611224 ()
  • 00860010611227 ()


  • Insulin syringe/needle, basic

DiaDoc - 00860010611210

No Description
INSULIFE LLC
30G 1cc 12.7mm
In Commercial Distribution

  • 10860010611217 ()
  • 00860010611210 ()


  • Insulin syringe/needle, basic

DiaDoc - 00860010611203

No Description
INSULIFE LLC
29G 1cc 12.7mm
In Commercial Distribution

  • 10860010611200 ()
  • 00860010611203 ()


  • Insulin syringe/needle, basic

AttenuRad - 00860010574591

CT thyroid shield
F&L Medical Products LLC
Standard
In Commercial Distribution

  • 00860010574591 ()


  • Radiation shielding panel, portable/mobile
  • Radiation shielding collar

AttenuRad - 00860010574584

CT eye shield
F&L Medical Products LLC
Standard
In Commercial Distribution

  • 00860010574584 ()


  • Radiation shielding panel, portable/mobile
  • Radiation shielding collar

AttenuRad - 00860010574577

CT breast shield large
F&L Medical Products LLC
Large
In Commercial Distribution

  • 00860010574577 ()


  • Radiation shielding apron
  • Radiation shielding panel, portable/mobile

AttenuRad - 00860010574560

CT Breast shield medium
F&L Medical Products LLC
Medium
In Commercial Distribution

  • 00860010574560 ()


  • Radiation shielding apron
  • Radiation shielding panel, portable/mobile

Hemaprep - 00860010522301

Blood smear instrument automated; Microscope slide maker IVD; portable, light weight (1 pound); no external power required.
J P Gilbert Company Inc
756300
In Commercial Distribution

  • 00860010522301 ()

  • Height: 5.4 Inch
  • Depth: 6.3 Inch
  • Width: 3.5 Inch
756300

  • Microscope slide maker IVD

BioReady - 00860010517628

BioReady 40nm Gold Citrate Nanospheres
Nanocomposix, LLC
40nm Gold Citrate Nanospheres
In Commercial Distribution

  • 00860010517628 ()
80-1018

  • Citrate staining/testing reagent IVD

BioReady - 00860010517611

BioReady, 40nm Gold PEG-COOH Gold Nanospheres
Nanocomposix, LLC
40nm Gold PEG-COOH Gold Nanospheres
In Commercial Distribution

  • 00860010517611 ()
80-1017

  • pH-adjusted buffer solution IVD

AcanthusTM - 00860010482643

Acanthus Nasal Bridge Protector (Bag of 60)
Acanthus Medical Creations LLC
NBP
Not in Commercial Distribution

  • 00860010482612 ()
  • 00860010482643 ()
NBP

  • Dressing-fixation skin adhesive tape, silicone

Azur Medical Company Inc. - 00860010450192

No Description
Azur Medical Company, Inc.
PCS10181K01
In Commercial Distribution

  • 00860010450192 ()


  • General-purpose syringe/needle
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