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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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CONTACT PLATE DELTA 20T - 04053755181315

No Description
Heine Optotechnik GmbH & Co. KG
STANDARD WITH SCALE
In Commercial Distribution

  • 04053755181315 ()
K-000.34.216

  • Dermatoscope, optical

CONTACT PLATE MINI3000 - 04053755124039

No Description
Heine Optotechnik GmbH & Co. KG
STANDARD WITH SCALE
In Commercial Distribution

  • 04053755124039 ()
D-000.78.117

  • Dermatoscope, optical

Needle Holder - 06974481839142

No Description
Guangzhou Improve Medical Instruments Co., Ltd.
With safety shield
In Commercial Distribution

  • 06974481839142 ()
  • 16974481839149 ()
  • 46974481839140 ()


  • Blood collection tube holder/needle

HUANFU - 26974239590077

No Description
Hubei Huanfu Plastic Products Co., Ltd.
white with printing
In Commercial Distribution

  • 06974239590004 ()
  • 26974239590077 ()


  • Basic bed sheet, single-use

Xplume Smoke Evacuator - 07290109141824

No Description
LUMENIS LTD.
With Vacuum Tubing
In Commercial Distribution

  • 07290109141824 ()


  • General/multiple surgical solid-state/carbon dioxide laser system

COULTER EPICS - 15099590572853

COULTER EPICS XL Flow Cytometer
Beckman Coulter, Inc.
XL with UPS
In Commercial Distribution

  • 15099590572853 ()
626551

  • Flow cytometry analyser IVD, semi-automated

COULTER EPICS - 15099590572846

COULTER EPICS XL-MCL Flow Cytometer
Beckman Coulter, Inc.
XL-MCL with UPS
In Commercial Distribution

  • 15099590572846 ()
626552

  • Flow cytometry analyser IVD, semi-automated

TRZ-CG POWER POSITIONING SYSTEM - 00754014710096

MCT SEAT - MAXX RAIL
Motion Concepts Inc
45T-R-MAXX (with vent)
Not in Commercial Distribution

  • 00754014710096 ()


  • Electric-motor-driven wheelchair, occupant-controlled

MODULAR POWER POSITIONING SYSTEM - 00754014710089

DROP SEAT - MAXX RAIL
Motion Concepts Inc
45T-12L-R-MAXX (with Vent)
Not in Commercial Distribution

  • 00754014710089 ()


  • Electric-motor-driven wheelchair, occupant-controlled

Reison - 07332339226206

Armboard with clamp and mattress
Stille AB
Armboard with clamp
In Commercial Distribution

  • 07332339226206 ()
514-50-3SR027

  • Fluoroscopy/angiography table, powered

MOC - 07290019141006

MRI multi-channel optical communication system
OPTOACOUSTICS LTD
IMROC-IR with OptoACTIVE
In Commercial Distribution

  • 07290019141006 ()


  • Patient audiovisual communication/entertainment system

Seventh Generation - 00732913451043

Organic Cotton Applicator Tampons, Super
SEVENTH GENERATION, INC.
Super, with applicator
Not in Commercial Distribution

  • 10732913451040 ()
  • 00732913451043 ()
  • 10732913447975 ()
45104

  • Menstrual tampon, unscented

Seventh Generation - 00732913451036

Organic Cotton Applicator Tampons, Regular
SEVENTH GENERATION, INC.
Regular, with applicator
Not in Commercial Distribution

  • 00732913451036 ()
  • 10732913451033 ()
  • 10732913447968 ()
45103

  • Menstrual tampon, unscented

Pusher, Knot 45cm with knurled handle with disc - 04057034396186

Pusher, Knot 45cm with knurled handle with disc ValveGate™
Geister Medizintechnik GmbH
34-7496L
In Commercial Distribution

  • 04057034396186 ()
34-7496L

  • Suture knot pusher, reusable

Retractor, Spinal, ring-handle, Längs with hinge with catch - 04057034097205

Retractor, Spinal, ring-handle, Längs with hinge with catch Titanium (BLUE) SpineControl™
Geister Medizintechnik GmbH
29-3013.TI
In Commercial Distribution

  • 04057034097205 ()
29-3013.TI

  • Surgical retraction system mounting frame, reusable

Retractor, Spinal, ring-handle, Längs with hinge with catch - 04057034097199

Retractor, Spinal, ring-handle, Längs with hinge with catch PEEK SpineControl™
Geister Medizintechnik GmbH
29-3013.PK
In Commercial Distribution

  • 04057034097199 ()
29-3013.PK

  • Surgical retraction system mounting frame, reusable

Y-Stent with Tracheal Posts with 1mm Wall Thickness - 00815347024035

E. Benson Hood Laboratories Y-Stent
HOOD, E BENSON LABORATORIES INC
YS1-1613-S
In Commercial Distribution

  • 00815347024035 ()


  • Tracheostomy tube, non-reinforced, non-customized, single-use

Y-Stent with Tracheal Posts with 1mm Wall Thickness - 00815347024028

E. Benson Hood Laboratories Y-Stent
HOOD, E BENSON LABORATORIES INC
YS1-1410-S
In Commercial Distribution

  • 00815347024028 ()


  • Tracheostomy tube, non-reinforced, non-customized, single-use

Y-Stent with Tracheal Posts with 1mm Wall Thickness - 00815347020099

E. Benson Hood Laboratories Y-Stent
HOOD, E BENSON LABORATORIES INC
YS1-1814-S
In Commercial Distribution

  • 00815347020099 ()


  • Tracheostomy tube, non-reinforced, non-customized, single-use

Y-Stent with Tracheal Posts with 1mm Wall Thickness - 00815347020082

E. Benson Hood Laboratories Y-Stent
HOOD, E BENSON LABORATORIES INC
YS1-1512-S
In Commercial Distribution

  • 00815347020082 ()


  • Tracheostomy tube, non-reinforced, non-customized, single-use

ESOP TRAY N°4 WITH LID WITH SKETCHES - 03661489453489

No Description
FOURNITURES HOSPITALIERES INDUSTRIE
245348
In Commercial Distribution

  • 03661489453489 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

ESOP TRAY N°3 WITH LID WITH SKETCHES - 03661489453472

No Description
FOURNITURES HOSPITALIERES INDUSTRIE
245347
In Commercial Distribution

  • 03661489453472 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

Left Ventricle Vent with Obturator,with Side Holes - 08033178004510

No Description
SORIN GROUP ITALIA SRL
W410-62
In Commercial Distribution

  • 38033178004511 ()
  • 08033178004510 ()


  • Chamber-decompression cardiac catheter

Left Atrium Vent with Obturator, with Side Holes - 08033178004503

No Description
SORIN GROUP ITALIA SRL
W420-62
In Commercial Distribution

  • 38033178004504 ()
  • 08033178004503 ()


  • Chamber-decompression cardiac catheter

ESOP TRAY N°2 WITH LID WITH SKETCHES - 03661489216817

No Description
FOURNITURES HOSPITALIERES INDUSTRIE
221681
In Commercial Distribution

  • 03661489216817 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

ESOP TRAY N°1 WITH LID WITH SKETCHES - 03661489216800

No Description
FOURNITURES HOSPITALIERES INDUSTRIE
221680
In Commercial Distribution

  • 03661489216800 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

RUSCH - 14026704662590

PEEP VALVE 22MM 10/BX
TELEFLEX INCORPORATED
IPN029672
In Commercial Distribution

  • 34026704662594 ()
  • 14026704662590 ()
  • 04026704541911 ()

  • PEEP Valve with Adapter
157200190

  • PEEP valve, single-use

Straumann - 04251574865144

Scanbody BASE
MEDENTiKA GmbH
025.0084
In Commercial Distribution

  • 04251574865144 ()

  • compatible with Straumann / SRA
025.0084

  • Dental implant abutment analog, intraoral-scanning, single-use

Vital™ MIS Spinal Fixation System - 00887868517426

No Description
BIOMET SPINE LLC
850M0042
In Commercial Distribution

  • 00887868517426 ()

  • Rod Inserter - With Stop
850M0042

  • General internal orthopaedic fixation system implantation kit

ROOTT - 00810149980145

Transfer, closed tray, with cap, R.
TRATE LLC
TR
In Commercial Distribution

  • 00810149981623 ()
  • 00810149980145 ()

  • closed tray, with cap


  • Dental implant suprastructure, temporary, preformed, single-use

RUSCH - 04026704541911

PEEP VALVE 22MM 10/BX
TELEFLEX INCORPORATED
IPN042601
In Commercial Distribution

  • 24026704541915 ()
  • 04026704541911 ()

  • PEEP Valve with Adapter
157200190

  • PEEP valve, single-use

Sonicator 740 plus 5 cm2 applicator - 00816864020203

Ultrasound and muscle stimulator plus 5 cm2 applicator
METTLER ELECTRONICS CORP.
ME 740
In Commercial Distribution

  • 00816864020203 ()

  • Weight: 3.75 Pound
  • 4.5 pounds with battery
ME 740

  • Physical therapy ultrasound system

Sys*Stim 240 - 00816864020166

Neuromuscular stimulator features 9 discrete waveforms (2-channel stim with optional laser)
METTLER ELECTRONICS CORP.
ME 240
In Commercial Distribution

  • 00816864020166 ()

  • 5.5 pounds with battery
  • Weight: 4.5 Pound
ME 240

  • Physical therapy transcutaneous electrical stimulation system, line-powered

GSO ACP1 Anterior Cervical Plate System - M9935097000

Implant Case
UNIFIED SPINE, LLC
509700
In Commercial Distribution

  • M9935097000 ()

  • Implant Case With Caddies


  • Surgical instrument/implant rack

OxyMask™ Aerosol - 10620974000348

OxyMask Kit with Nebulizer
Southmedic Incorporated
OMN-1025
In Commercial Distribution

  • 10620974000348 ()
  • 00620974000341 ()

  • OxyMask Kit with Nebulizer
OMN-1025

  • Vortex oxygen face mask

MEDENTiKA - 04251574847690

Scanbody retention screw
MEDENTiKA GmbH
PR 60 SB
In Commercial Distribution

  • EMKAPR60SB9 ()
  • 04251574847690 ()

  • compatible with Straumann / Pure
PR 60 SB

  • Dental implant suprastructure, permanent, preformed

MEDENTiKA - 04251574847683

Scanbody
MEDENTiKA GmbH
PR 1400
In Commercial Distribution

  • EMKAPR14009 ()
  • 04251574847683 ()

  • compatible with Straumann / Pure
PR 1400

  • Dental implant suprastructure, temporary, preformed, reusable

MEDENTiKA - EMKA609419

Modelling cap set
MEDENTiKA GmbH
6-09-41
In Commercial Distribution

  • 04251574852526 ()
  • EMKA609419 ()

  • compatible with all systems
6-09-41

  • Dental appliance fabrication material, thermoplastic

MEDENTiKA - EMKA609399

Modelling cap set
MEDENTiKA GmbH
6-09-39
In Commercial Distribution

  • 04251574852502 ()
  • EMKA609399 ()

  • compatible with all systems
6-09-39

  • Dental appliance fabrication material, thermoplastic

MEDENTiKA - EMKA609379

Modelling cap set
MEDENTiKA GmbH
6-09-37
In Commercial Distribution

  • 04251574852014 ()
  • EMKA609379 ()

  • compatible with all systems
6-09-37

  • Dental appliance fabrication material, thermoplastic

MEDENTiKA - EMKA609369

Modelling cap set
MEDENTiKA GmbH
6-09-36
In Commercial Distribution

  • 04251574852007 ()
  • EMKA609369 ()

  • compatible with all systems
6-09-36

  • Dental appliance fabrication material, thermoplastic

MEDENTiKA - EMKA609359

Modelling cap set
MEDENTiKA GmbH
6-09-35
In Commercial Distribution

  • 04251574851994 ()
  • EMKA609359 ()

  • compatible with all systems
6-09-35

  • Dental appliance fabrication material, thermoplastic

MEDENTiKA - EMKA609349

Modelling cap set
MEDENTiKA GmbH
6-09-34
In Commercial Distribution

  • 04251574851987 ()
  • EMKA609349 ()

  • compatible with all systems
6-09-34

  • Dental appliance fabrication material, thermoplastic

MEDENTiKA - EMKA609339

Modelling cap set
MEDENTiKA GmbH
6-09-33
In Commercial Distribution

  • 04251574851970 ()
  • EMKA609339 ()

  • compatible with all systems
6-09-33

  • Dental appliance fabrication material, thermoplastic

MEDENTiKA - EMKA609329

Modelling cap set
MEDENTiKA GmbH
6-09-32
In Commercial Distribution

  • 04251574851963 ()
  • EMKA609329 ()

  • compatible with all systems
6-09-32

  • Dental appliance fabrication material, thermoplastic

MEDENTiKA - EMKA609319

Modelling cap set
MEDENTiKA GmbH
6-09-31
In Commercial Distribution

  • 04251574851956 ()
  • EMKA609319 ()

  • compatible with all systems
6-09-31

  • Dental appliance fabrication material, thermoplastic

MEDENTiKA - EMKA609309

Modelling cap set
MEDENTiKA GmbH
6-09-30
In Commercial Distribution

  • 04251574851949 ()
  • EMKA609309 ()

  • compatible with all systems
6-09-30

  • Dental appliance fabrication material, thermoplastic

MEDENTiKA - EMKA609299

Modelling cap set
MEDENTiKA GmbH
6-09-29
In Commercial Distribution

  • 04251574851932 ()
  • EMKA609299 ()

  • compatible with all systems
6-09-29

  • Dental appliance fabrication material, thermoplastic

MEDENTiKA - EMKA609289

Modelling cap set
MEDENTiKA GmbH
6-09-28
In Commercial Distribution

  • 04251574851925 ()
  • EMKA609289 ()

  • compatible with all systems
6-09-28

  • Dental appliance fabrication material, thermoplastic

MEDENTiKA - EMKA609279

Modelling cap set
MEDENTiKA GmbH
6-09-27
In Commercial Distribution

  • 04251574851918 ()
  • EMKA609279 ()

  • compatible with all systems
6-09-27

  • Dental appliance fabrication material, thermoplastic
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