SEARCH RESULTS FOR: (*One Satoshitg:(@hkotccc)tFIg*)(1754743 results)

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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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ExpertCor Routine - 00864608000226

ExpertCor Routine plasma set consists of unassayed, ready-to-use human plasmas across reportable range of prothrombin time (PT), activated partial thromboplastin time (APTT), Fibrinogen and INR. The plasma set is intended for use in the quality control of coagulation assay performed on Coagulation Analyzers.
DSRV Inc
01306
In Commercial Distribution

  • 00864608000226 ()


  • Multiple coagulation factor IVD, control

Magellan 2200 Model - 3 - 00864604000367

No Description
OCEANIC MEDICAL PRODUCTS, INC.
1
Not in Commercial Distribution

  • 00864604000367 ()


  • Anaesthesia unit, mobile

Magellan 2200 Model - 3 - 00864604000343

No Description
OCEANIC MEDICAL PRODUCTS, INC.
1
Not in Commercial Distribution

  • 00864604000343 ()


  • Anaesthesia unit, mobile

Magellan 2200 Model - 2 - 00864604000336

No Description
OCEANIC MEDICAL PRODUCTS, INC.
1
Not in Commercial Distribution

  • 00864604000336 ()


  • Anaesthesia unit, mobile

Magellan 2200 Model - 1 - 00864604000329

No Description
OCEANIC MEDICAL PRODUCTS, INC.
1
Not in Commercial Distribution

  • 00864604000329 ()


  • Anaesthesia unit, mobile

AccuPlan System - 00864582000298

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

AccuPlan System - 00864582000281

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

DeScribe Transparent PFD Patch - 00864525000200

Individually packaged DeScribe PFD Patch (each)
On Light Sciences, Inc.
PFD-462
In Commercial Distribution

  • 00864525000200 ()
  • 10864525000207 ()


  • Synthetic polymer semi-permeable film dressing, adhesive, non-sterile

iLux - 00864461000418

No Description
Alcon Laboratories, Inc.
2020-D
In Commercial Distribution

  • 00864461000418 ()
  • 10864461000415 ()
2020-D

  • Eyelid thermal pulsation system applicator, single-use

Ultramatrix EUS Radial Balloon for Olympus & Pentax - 00864390000350

No Description
N. M. BEALE COMPANY, INC.
USB-OR
Not in Commercial Distribution

  • 00864390000350 ()
USB-OR

  • Ultrasound endoscope balloon, synthetic polymer

Ultramatrix EUS Linear Balloon for Pentax - 00864390000343

No Description
N. M. BEALE COMPANY, INC.
USB-PL
Not in Commercial Distribution

  • 00864390000343 ()
USB-PL

  • Ultrasound endoscope balloon, synthetic polymer

Ultramatrix EUS Linear Balloon for Olympus - 00864390000336

No Description
N. M. BEALE COMPANY, INC.
USB-OL
Not in Commercial Distribution

  • 00864390000336 ()
USB-OL

  • Ultrasound endoscope balloon, synthetic polymer

Baleen Polyp Trap - 00864390000305

No Description
N. M. BEALE COMPANY, INC.
NBPT520
Not in Commercial Distribution

  • 00864390000305 ()
NBPT520

  • General specimen container IVD, no additive/medium

3CPM Company, Inc - 00864359000223

3CPM Company Electrogastrogram Research/Waterload platform Unit. Device uses ECG-like technology to capture the electrical waves of the stomach and intestines.
3CPM CO., INC.
2.09e
In Commercial Distribution

  • 00864359000223 ()


  • Myoelectric gastrointestinal motility analysis system
  • Electrocardiograph, professional, single-channel

Bernafon - 05711584084465

ZR5, KIT 312 2.4G NFM 85 PB R BE ZERENA 5
Bernafon AG
186060
In Commercial Distribution

  • 05711584084465 ()


  • Air-conduction hearing aid, in-the-ear

Bernafon - 05711584084434

ZR5, KIT 312 2.4G NFM 75 L BE ZERENA 5
Bernafon AG
186057
In Commercial Distribution

  • 05711584084434 ()


  • Air-conduction hearing aid, in-the-ear

Bernafon - 05711584084410

ZR7, KIT 312 NFM PB T L BE ZERENA 7
Bernafon AG
186039
In Commercial Distribution

  • 05711584084410 ()


  • Air-conduction hearing aid, in-the-ear

Bernafon - 05711584084397

ZR7, KIT 312 NFM PB L BE ZERENA 7
Bernafon AG
186037
In Commercial Distribution

  • 05711584084397 ()


  • Air-conduction hearing aid, in-the-ear

Bernafon - 05711584084373

ZR7, KIT 312 NFM L BE ZERENA 7
Bernafon AG
186035
In Commercial Distribution

  • 05711584084373 ()


  • Air-conduction hearing aid, in-the-ear

Bernafon - 05711584084359

ZR7, KIT 312 NFM 90 PB L BE ZERENA 7
Bernafon AG
186033
In Commercial Distribution

  • 05711584084359 ()


  • Air-conduction hearing aid, in-the-ear

Heron IOS - 00864206000406

Heron IOS system is an optical impression system used to record the topographical characteristics of teeth, dental impressions, or stone models for use in the computer aided design and manufacturing of dental restorative prosthetic devices. Heron IOS system consists of a handheld scanner with base, tips (reusable upon autoclave), cables and software.
3D IMAGING AND SIMULATION CORP. AMERICAS
IOS-FP-71-001
In Commercial Distribution

  • 00864206000406 ()


  • Dental milling system, CAD/CAM, chairside

Bernafon - 05711584084335

ZR7, KIT 312 NFM 90 L BE ZERENA 7
Bernafon AG
186031
In Commercial Distribution

  • 05711584084335 ()


  • Air-conduction hearing aid, in-the-ear

Bernafon - 05711584084311

ZR7, KIT 312 NFM 85 PB T L BE ZERENA 7
Bernafon AG
186029
In Commercial Distribution

  • 05711584084311 ()


  • Air-conduction hearing aid, in-the-ear

ImPACT Quick Test - 00864127000356

ImPACT Quick Test is intended for use as a computerized cognitive test to aid in the assessment of concussion in individuals ages 12-70
IMPACT APPLICATIONS, INC.
2
In Commercial Distribution

  • 00864127000356 ()


  • Cognitive assessment software

Bernafon - 05711584084298

ZR7, KIT 312 NFM 85 PB L BE ZERENA 7
Bernafon AG
186027
In Commercial Distribution

  • 05711584084298 ()


  • Air-conduction hearing aid, in-the-ear

Cognitive Impairment Screener - 00864127000332

No Description
IMPACT APPLICATIONS, INC.
1
In Commercial Distribution

  • 00864127000332 ()


  • Cognitive assessment software

Bernafon - 05711584084274

ZR7, KIT 312 NFM 85 L BE ZERENA 7
Bernafon AG
186025
In Commercial Distribution

  • 05711584084274 ()


  • Air-conduction hearing aid, in-the-ear

Bernafon - 05711584084243

ZR7, KIT 312 NFM 75 R BE ZERENA 7
Bernafon AG
186022
In Commercial Distribution

  • 05711584084243 ()


  • Air-conduction hearing aid, in-the-ear

Bernafon - 05711584084182

ZR7, KIT 312 2.4G NFM R BE ZERENA 7
Bernafon AG
186016
In Commercial Distribution

  • 05711584084182 ()


  • Air-conduction hearing aid, in-the-ear

Biotronix Healthcare Syringes - 00864085000412

Disposable 3cc LL Syringe with Needle 23G x 1 1/2, Each
BIOTRONIX HEALTHCARE INDUSTRIES, INC.
GE12041
In Commercial Distribution

  • 20864085000416 ()
  • 10864085000419 ()
  • 00864085000412 ()

  • Disposable 3cc LL Syringe with Needle 23G x 1 1/2, Each
GE12041

  • Hypodermic needle, single-use
  • General-purpose syringe, single-use

Biotronix Healthcare Syringes - 00864085000405

Disposable 10CC, LL Syringe, W/Needle, 21G x 1 1/2", Each,
BIOTRONIX HEALTHCARE INDUSTRIES, INC.
GE12085
In Commercial Distribution

  • 20864085000409 ()
  • 10864085000402 ()
  • 00864085000405 ()

  • Disposable 10CC, LL Syringe, W/Needle, 21G x 1 1/2", Each,
GE12085

  • Hypodermic needle, single-use
  • General-purpose syringe, single-use

CLS - 00864039000413

Saphenous Vein Cannula
COASTAL LIFE SYSTEMS, INC.
201006-000
In Commercial Distribution

  • 10864039000410 ()
  • 00864039000413 ()


  • Vascular irrigation cannula, cardiac vessel graft

Life Sensing Instruments, Inc. - 00864037000392

Software which displays a patient's vital signs as part of the HTS820 patient-monitoring system.
LIFE SENSING INSTRUMENTS, INC.
TrensCenter 5.400
In Commercial Distribution

  • 00864037000392 ()


  • Multiple-patient intensive/general healthcare physiologic monitoring system

Life Sensing Instruments, Inc. - 00864037000385

Software which displays a patient's vital signs as part of the HTS820 patient-monitoring system.
LIFE SENSING INSTRUMENTS, INC.
TrensCenter VSP 1.000
In Commercial Distribution

  • 00864037000385 ()


  • Multiple-patient intensive/general healthcare physiologic monitoring system

Life Sensing Instruments, Inc. - 00864037000378

Transmitter which is part of a multi-patient physiologic monitoring system
LIFE SENSING INSTRUMENTS, INC.
BWI-D
In Commercial Distribution

  • 00864037000378 ()


  • Multiple-patient intensive/general healthcare physiologic monitoring system

Life Sensing Instruments, Inc. - 00864037000354

Software which displays a patient's vital signs as part of the HTS820 patient-monitoring system.
LIFE SENSING INSTRUMENTS, INC.
TrensCenter 5.300
In Commercial Distribution

  • 00864037000354 ()


  • Multiple-patient intensive/general healthcare physiologic monitoring system

Life Sensing Instruments, Inc. - 00864037000330

Windows 7 Tower which is part of a multi-patient physiologic monitoring system
LIFE SENSING INSTRUMENTS, INC.
HTS820 Windows 7
In Commercial Distribution

  • 00864037000330 ()


  • Multiple-patient intensive/general healthcare physiologic monitoring system

Life Sensing Instruments, Inc. - 00864037000323

Receiver which is part of a multi-patient physiologic monitoring system
LIFE SENSING INSTRUMENTS, INC.
T-Link Receiver
In Commercial Distribution

  • 00864037000323 ()


  • Multiple-patient intensive/general healthcare physiologic monitoring system

Life Sensing Instruments, Inc. - 00864037000316

Transmitter which is part of a multi-patient physiologic monitoring system
LIFE SENSING INSTRUMENTS, INC.
TM8B Transmitter
In Commercial Distribution

  • 00864037000316 ()


  • Multiple-patient intensive/general healthcare physiologic monitoring system

Life Sensing Instruments, Inc. - 00864037000309

Transmitter which is part of a multi-patient physiologic monitoring system
LIFE SENSING INSTRUMENTS, INC.
TM8D Transmitter
In Commercial Distribution

  • 00864037000309 ()


  • Multiple-patient intensive/general healthcare physiologic monitoring system

Bernafon - 05711584084151

ZR7, KIT 312 2.4G NFM 90 L BE ZERENA 7
Bernafon AG
186013
In Commercial Distribution

  • 05711584084151 ()


  • Air-conduction hearing aid, in-the-ear

Bernafon - 05711584084113

ZR7, KIT 312 2.4G NFM 85 PB L BE ZERENA 7
Bernafon AG
186009
In Commercial Distribution

  • 05711584084113 ()


  • Air-conduction hearing aid, in-the-ear

DenSureFit - 00863995000109

DenSureFit is an over-the-counter soft reline kit. It consists of 2 applicators of vinyl polysiloxane, 1 vial primer, 2 stick applicators and 1 IFU. The kit is intended to reline one denture plate. It is intended to provide temporary relief from ill-fitting dentures until a dentist can be seen.
OTC DENTAL CORPORATION
DSF212.00
In Commercial Distribution

  • 00863995000109 ()


  • Denture reliner, soft, home-use

TMM - NG/OG (Tactical Medical Module - Nasogastric/Orogastric) - 00863970000476

No Description
Altitude Technologies Inc.
5007
In Commercial Distribution

  • 00863970000476 ()


  • Nasogastric/orogastric tube

Bernafon - 05711584083994

ZR9, KIT 312 NFM 90 PB L BE ZERENA 9
Bernafon AG
185928
In Commercial Distribution

  • 05711584083994 ()


  • Air-conduction hearing aid, in-the-ear

Bernafon - 05711584083970

ZR9, KIT 312 NFM 90 L BE ZERENA 9
Bernafon AG
185926
In Commercial Distribution

  • 05711584083970 ()


  • Air-conduction hearing aid, in-the-ear

RNARetain - 00863840000285

No Description
ASURAGEN, INC.
84001
In Commercial Distribution

  • 00863840000285 ()
84001

  • General specimen container IVD, additive/medium

Bernafon - 05711584083956

ZR9, KIT 312 NFM 85 PB T L BE ZERENA 9
Bernafon AG
185924
In Commercial Distribution

  • 05711584083956 ()


  • Air-conduction hearing aid, in-the-ear

Bernafon - 05711584083932

ZR9, KIT 312 NFM 85 PB L BE ZERENA 9
Bernafon AG
185922
In Commercial Distribution

  • 05711584083932 ()


  • Air-conduction hearing aid, in-the-ear

NovoGro Putty - 00863787000478

NovoGro Putty is intended to be hydrated with ultra-pure water and gently packed into bony voids or gaps of the skeletal system.
OSTEONOVUS, INC.
NGC10X
In Commercial Distribution

  • 00863787000478 ()

  • 10 cc


  • Bone matrix implant, synthetic, non-antimicrobial
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