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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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NA - 04037691144184

No Description
Maquet Cardiopulmonary AG
Rigid sucker with mini-tip
Not in Commercial Distribution

  • 04037691064147 ()
  • 04037691144184 ()

  • Steel tube inner diameter 3.4 Millimeter
  • Tip outer diamteter 9 French
  • Connector 1/4 Inch
  • Length: 27 Centimeter
70100.4972

  • Suction system catheter, general-purpose

CAM - 00840682125291

CAM CONNECT 14 WITH BARCODE
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
Connect 14 with Barcode
In Commercial Distribution

  • 00840682125291 ()
2091685-001

  • Electrocardiograph, professional, multichannel

AC Outlet Strip - 04033817900870

No Description
LivaNova Deutschland GmbH
with isolation transformer (US)
In Commercial Distribution

  • 04033817900870 ()


  • Cardiopulmonary bypass system, roller type

Headrest - 07640132986600

No Description
Haag-Streit AG
With Lower Part Silver
In Commercial Distribution

  • 07640132986600 ()
1420186

  • Ophthalmic examination slit lamp

Headrest - 07640132986563

No Description
Haag-Streit AG
With Lower Part Silver
In Commercial Distribution

  • 07640132986563 ()
1420182

  • Ophthalmic examination slit lamp

REMstar - 00606959036888

REMstar with Humidifier, International
Respironics, Inc.
REMstar, with Humidifier, INTL
Not in Commercial Distribution

  • 00606959036888 ()
IN171H

  • Heated respiratory humidifier
  • Home CPAP unit

UNIVENT TUBE (TCB TYPE) - 04544050123822

ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is indicated for use in airway management of surgical patients to perform one-lung ventilation.
FUJI SYSTEMS CORPORATION
I.D. 4.5MM, WITH CUFF
In Commercial Distribution

  • 14544050123829 ()
  • 04544050123822 ()
  • 04544050055161 ()
1202720

  • Endobronchial tube

UNIVENT TUBE (TCB TYPE) - 04544050055161

ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is indicated for use in airway management of surgical patients to perform one-lung ventilation.
FUJI SYSTEMS CORPORATION
I.D. 4.5MM, WITH CUFF
In Commercial Distribution

  • 04544050055161 ()
1202720

  • Endobronchial tube

EZ-Grip - 05060170183380

Assisted Reproduction Microtools (Pipettes)
RESEARCH INSTRUMENTS LIMITED
EZ-Grip with Comfort Rest
In Commercial Distribution

  • 05060170183380 ()
7-72-2802

  • Assisted reproduction microtool

ORTHO ARCH - D9092266571

.018 LOWER BLACK SATIN SE NITINOL WITH DIMPLE (10)***DISCONTINUED/ WHILE SUPPLIES LAST. NON-REFUNDABLE OR RETURNABLE***
Ortho Arch Company Inc
.018 LOWER WITH DIMPLE
In Commercial Distribution

  • D9092266571 ()
226-657

  • Orthodontic archwire

ORTHO ARCH - D9092266561

.018 UPPER BLACK SATIN SE NITINOL WITH DIMPLE (10)***DISCONTINUED/ WHILE SUPPLIES LAST. NON-REFUNDABLE OR RETURNABLE***
Ortho Arch Company Inc
.018 UPPER WITH DIMPLE
In Commercial Distribution

  • D9092266561 ()
226-656

  • Orthodontic archwire

Shower Seat - 05707581000775

No Description
Ropox A/S
Backrest, with Arm Support
In Commercial Distribution

  • 05707581000775 ()
40-43025-3

  • Shower seat, non-powered

Vario - 05707581000584

No Description
Ropox A/S
With bed guards, 190x70cm
In Commercial Distribution

  • 05707581000584 ()
40-30811-3

  • Bathing/changing table, stationary

Vario - 05707581000577

No Description
Ropox A/S
With bed guards, 180x70cm
In Commercial Distribution

  • 05707581000577 ()
40-30810-3

  • Bathing/changing table, stationary

Vario - 05707581000560

No Description
Ropox A/S
With bed guards, 160x70cm
In Commercial Distribution

  • 05707581000560 ()
40-30808-3

  • Bathing/changing table, stationary

Vario - 05707581000553

No Description
Ropox A/S
With bed guards, 140x70cm
In Commercial Distribution

  • 05707581000553 ()
40-30806-3

  • Bathing/changing table, stationary

Vario - 05707581000546

No Description
Ropox A/S
With bed guards, 120x70cm
In Commercial Distribution

  • 05707581000546 ()
40-30804-3

  • Bathing/changing table, stationary

Showerbed - 05707581000485

No Description
Ropox A/S
With back support, 210cm
In Commercial Distribution

  • 05707581000485 ()
40-25079-2

  • Bathing/changing table, stationary

Showerbed - 05707581000478

No Description
Ropox A/S
With back support, 178cm
In Commercial Distribution

  • 05707581000478 ()
40-25076-2

  • Bathing/changing table, stationary

Showerbed - 05707581000461

No Description
Ropox A/S
With back support, 146cm
In Commercial Distribution

  • 05707581000461 ()
40-25073-2

  • Bathing/changing table, stationary

Zuvo - 00850041729152

Zuvo 16 with Vida Go, speech generating device
Talk To ME Technologies, LLC
16 with Vida Go
In Commercial Distribution

  • 00850041729152 ()


  • Voice synthesizer/digitizer

zuvo - 00850041729145

Zuvo 12 with Vida Go, speech generating device
Talk To ME Technologies, LLC
12 with Vida Go
In Commercial Distribution

  • 00850041729145 ()


  • Voice synthesizer/digitizer

zuvo - 00850041729107

zuvo 16 with eyespeak inspo, speech generating device
Talk To ME Technologies, LLC
16 with eyespeak inspo
In Commercial Distribution

  • 00850041729107 ()


  • Voice synthesizer/digitizer

zuvo - 00850041729091

zuvo 12 with eyespeak inspo, speech generating device
Talk To ME Technologies, LLC
12 with eyespeak inspo
In Commercial Distribution

  • 00850041729091 ()


  • Voice synthesizer/digitizer

Timm Medical - 00857312008183

No Description
POS-T-VAC INC
Esteem Cylinder with Insert
In Commercial Distribution

  • 00857312008183 ()
1250

  • Penile vacuum device

GN Otometrics A/S - 05713315005701

No Description
Natus Medical Denmark ApS
REM Tube with ruler
In Commercial Distribution

  • 05713315005701 ()


  • Hearing aid tester, electrical

GN Otometrics A/S - 05713315005527

1081 AURICAL (PMM, C&S) with HI-PRO (US only)
Natus Medical Denmark ApS
1081 AURICAL with HI-PRO
In Commercial Distribution

  • 05713315005527 ()
8-04-14536

  • Speech audiometer
  • Tone audiometer

GN Otometrics A/S - 05713315002373

No Description
Natus Medical Denmark ApS
PROBE TIP WITH TUBES
In Commercial Distribution

  • 05713315002373 ()


  • Impedance audiometer

Dorado KT Cart with Evox (240V) - 00627825005296

No Description
Laborie Medical Technologies Canada ULC
Dorado KT with EVOX
In Commercial Distribution

  • 00627825005296 ()


  • Evoked-potential graphic recording system

Dorado KT Cart with Evox (120V) - 00627825005289

No Description
Laborie Medical Technologies Canada ULC
Dorado KT with EVOX
In Commercial Distribution

  • 00627825005289 ()


  • Evoked-potential graphic recording system

Siemens - 05711781000749

Siemens UNITY 3 WITH INSERT
Ws Audiology Usa, Inc.
UNITY 3 WITH INSERT
Not in Commercial Distribution

  • 05711781000749 ()
10824331

  • Audiometric/hearing aid tester

ProSomnus EVO Sleep and Snore Device with Patient Monitoring - 00863039000492

No Description
PROSOMNUS SLEEP TECHNOLOGIES
EVO with Patient Monitoring
In Commercial Distribution

  • 00863039000492 ()


  • Mandible-repositioning sleep-disordered breathing orthosis

Pos-T-Vac - 00656535000727

No Description
POS-T-VAC INC
BOS-2000-3 International With RL
In Commercial Distribution

  • 00656535000727 ()


  • Penile vacuum device

Sysmex UF1000i, Automated Urine Particle Analyzer with Urinalysis WAM Software - 00664369000639

Fully Automated Urine Cell Analyzer UF-1000i UF WAM
Sysmex America, Inc.
UF-1000i with UF WAM
In Commercial Distribution

  • 00664369000639 ()


  • Flow cytometry analyser IVD

Epredia - 05051663010191

No Description
SHANDON DIAGNOSTICS LIMITED
NX50 CRYOSTAR WITH HEIGHT
In Commercial Distribution

  • 05051663010191 ()


  • Cryostat microtome IVD

Epredia - 05051663005258

No Description
SHANDON DIAGNOSTICS LIMITED
HM 355S With STS
In Commercial Distribution

  • 05051663005258 ()


  • Rotary microtome IVD

Epredia - 05051663003896

No Description
SHANDON DIAGNOSTICS LIMITED
NX70 CRYOSTAR WITH HOMVPD
In Commercial Distribution

  • 05051663003896 ()


  • Cryostat microtome IVD

Epredia - 05051663003889

No Description
SHANDON DIAGNOSTICS LIMITED
NX70 CRYOSTAR WITH HOMVP
In Commercial Distribution

  • 05051663003889 ()


  • Cryostat microtome IVD

Epredia - 05051663003872

Cryostar NX70 Cryostat
SHANDON DIAGNOSTICS LIMITED
NX70 with HOMPD, 220-240V
In Commercial Distribution

  • 05051663003872 ()
957050L

  • Cryostat microtome IVD

Epredia - 05051663003865

Cryostar NX70 Cryostat
SHANDON DIAGNOSTICS LIMITED
NX70 with HOMP, 220-240V
In Commercial Distribution

  • 05051663003865 ()
957040L

  • Cryostat microtome IVD
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