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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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DIASAFE®plusUS - 00840861102136

No Description
Fresenius Medical Care Renal Therapies Group, LLC
F00007039
In Commercial Distribution

  • 10840861102133 ()
  • 00840861102136 ()

  • Area/Surface Area: 2.1 Square meter
F00007039

  • Haemodialysis system dialysate pyrogen filter

Diacap® - 04046963178116

DIACAP ULTRA DF FILTER CA & US
B.Braun Avitum AG
7107368
In Commercial Distribution

  • 04046963178109 ()
  • 04046963178116 ()
7107368

  • Haemodialysis system dialysate pyrogen filter

Synergy - 00613994532398

PLNG STATION 9734048 STEALTHSTATION S7
MEDTRONIC NAVIGATION, INC.
9734048
In Commercial Distribution

  • 00613994532398 ()


  • Stereotactic surgery system workstation

Stealthstation® S7™ - 00613994792921

PLNG STATION 9734669R RWK S7
MEDTRONIC NAVIGATION, INC.
9734669R
In Commercial Distribution

  • 00613994792921 ()


  • Stereotactic surgery system workstation

NA - 00643169777316

PLNG STATION 9734048R STEALTHSTATION S7
MEDTRONIC NAVIGATION, INC.
9734048R
In Commercial Distribution

  • 00643169777316 ()


  • Stereotactic surgery system workstation

Filter for dialysate purification - 04987671030214

The EF-02D filter is a sterile dialysis fluid filter that produces ultrapure dialysate as defined in ANSI/AAMI/ISO 23500. The filter(s) are used as part of Hemodialysis machine hydraulic section.
NIKKISO CO.,LTD.
EF-02D
In Commercial Distribution

  • 24987671030218 ()
  • 04987671030214 ()


  • Haemodialysis system dialysate pyrogen filter

TQE Plus Endotoxin 10" Filter Flat 222 Head - 00868277000440

The TQE PlusEndotoxinFilter(Flat)is a hollow fiber ultrafilter that retains bacteria and endotoxin from fluid.
NEPHROS, INC.
TQE0.005-10HP3E
In Commercial Distribution

  • 10868277000447 ()
  • 00868277000440 ()
  • 20868277000444 ()


  • Haemodialysis system dialysate pyrogen filter

TQE Plus Endotoxin 20" Filter Flat 222 Head - 00868277000457

The TQE PlusEndotoxinFilter(Flat)is a hollow fiber ultrafilter that retains bacteria and endotoxin from fluid.
NEPHROS, INC.
TQE0.005-20HP3E
In Commercial Distribution

  • 10868277000454 ()
  • 00868277000457 ()
  • 20868277000451 ()


  • Haemodialysis system dialysate pyrogen filter

Nipro Ultrafilter - 00383790008860

Filter for clean dialysate and water
NIPRO MEDICAL CORPORATION
CF+609N
In Commercial Distribution

  • 40383790008868 ()
  • 00383790008860 ()


  • Haemodialysis system dialysate pyrogen filter

StealthStation® AXIEM™ System - 00763000241483

AXIEM KIT 9732750 PORTABLE PRE-BUILD
MEDTRONIC NAVIGATION, INC.
9732750
In Commercial Distribution

  • 00763000241483 ()


  • Stereotactic surgery system workstation

StealthStation® AXIEM™ System - 00613994109477

AXIEM KIT, 9732750, PORTABLE PRE-BUILD
MEDTRONIC NAVIGATION, INC.
9732750
In Commercial Distribution

  • 00613994109477 ()


  • Stereotactic surgery system workstation

PDT, Inc. - 00813677025210

Kit Contains: R138 Montana Jack® Scaler R061 Barnhart 5-6 R030 Amazing Gracey™ 15-16
PDT, INC.
R908 - PDT Demo Wallet 3 Pack - Hygiene
In Commercial Distribution

  • 00813677025210 ()
R908

  • Periodontal curette
  • Manual dental scaler, reusable

OPTION, NL4X00 WS-120V-S - 10815411020823

No Description
NEUROLOGICA CORP.
0-00132-001
In Commercial Distribution

  • 10815411020823 ()


  • CT system workstation

OPTION, NL4X00 WS-240V - 10815411020816

No Description
NEUROLOGICA CORP.
0-00132-003
In Commercial Distribution

  • 10815411020816 ()


  • CT system workstation

OPTION, NL4X00 WS-240V-S - 10815411020809

No Description
NEUROLOGICA CORP.
0-00132-002
In Commercial Distribution

  • 10815411020809 ()


  • CT system workstation

Scanner Drive System - 10815411020106

No Description
NEUROLOGICA CORP.
0-00116-001
In Commercial Distribution

  • 10815411020106 ()


  • CT system workstation

OPTION, WS CART NL4000 - 10815411020229

No Description
NEUROLOGICA CORP.
0-00132-001
In Commercial Distribution

  • 10815411020229 ()


  • CT system workstation

Mobile ENT Computer Cart, Assembly - 10815411020212

No Description
NEUROLOGICA CORP.
10-00159-001
In Commercial Distribution

  • 10815411020212 ()


  • CT system workstation

SmartByte Device - 00860001615326

Custom made oral device used during meals to reduce the capacity of the oral cavity and slow/reduce food intake.
SCIENTIFIC INTAKE LIMITED CO.
SI-001.01
In Commercial Distribution

  • 00860001615326 ()


  • Oral intake restriction kit

TruSPECT - 07290108670233

TruSPECT Radiological Image Processing Station
SPECTRUM DYNAMICS MEDICAL, INC
STANDALONE PROCESSING STATION
In Commercial Distribution

  • 07290108670233 ()
8010290-01

  • SPECT system workstation

D-SPECT ® processing and Reviewing Workstation - 07290108670080

Single Photon Emission Computed Tomography system, stand alone processing station.
SPECTRUM DYNAMICS MEDICAL, INC
Stand Alone
Not in Commercial Distribution

  • 07290108670080 ()
8010113-01

  • SPECT system workstation

IntelliSpace Portal IX - 00884838083653

The IntelliSpace Portal IX V6.5 processes clinical images from a SBI* series that was generated by Philips IQon system and enables advanced visualization of the images. When used by qualified personnel, it provides useful diagnostic information. IntelliSpace Portal IX V6.5 can be used remotely by multiple users with compatible devices *SBI: Spectral Base Images. A set of dataset that are being used as the inputs for calculation of Spectral results that are being used for reading.
Philips Medical Systems Nederland B.V.
6.5
Not in Commercial Distribution

  • 00884838083653 ()


  • CT system workstation

IntelliSpace Portal - 00884838083646

The IntelliSpace Portal V6.5 processes clinical images from a SBI* series that was generated by Philips IQon system and enables advanced visualization of the images. When used by qualified personnel, it provides useful diagnostic information. IntelliSpace Portal V6.5 can be used remotely by multiple users with compatible devices *SBI: Spectral Base Images. A set of dataset that are being used as the inputs for calculation of Spectral results that are being used for reading.
Philips Medical Systems Nederland B.V.
6.5
Not in Commercial Distribution

  • 00884838083646 ()


  • CT system workstation

Invivo - 00884838081758

SensaVue Cart Assembly
Philips DS North America LLC
4535-303-46291
Not in Commercial Distribution

  • 00884838081758 ()
453530346291

  • MRI system workstation

PDT, Inc. - 00813677024510

Kit Includes: R067 Columbia 4L-4R R138R Montana Jack® Rigid R120 Montana 4-5™ Scaler R030R Amazing Gracey™ 15-16 Rigid T007B-F FlipTop™ Cassette 'B' - Fixed Rack 7 R028R Amazing Gracey™ 13-14 Rigid
PDT, INC.
R978 Gross Debridement Kit
In Commercial Distribution

  • 00813677024510 ()
R978

  • Periodontal curette
  • Manual dental scaler, reusable
  • Instrument tray, reusable

NORDENT MANUFACTURING INC - 00840018647466

SCALER, DOUBLE END, TRADE IN, OFFSET SICKLE MONTANA JACK UNIVERSAL R138 THIN BLADE, #6 RELYANT HANDLE
NORDENT MANUFACTURING INC
TSCNMJF
In Commercial Distribution

  • 00840018647466 ()


  • Manual dental scaler, reusable

CURETTE MONTANA JACK ROUND KNURLED HANDLE - D928705164RK0

No Description
W.H. Holden, Inc.
70-5164RK
In Commercial Distribution

  • D928705164RK0 ()


  • Periodontal curette

PDT, Inc. - 00813677020826

No Description
PDT, INC.
Montana 4-5 Scaler
In Commercial Distribution

  • 00813677020826 ()
R120

  • Manual dental scaler, reusable

ONLINE TDM Vancomyin Gen.3 - 04015630934416

No Description
Roche Diagnostics GmbH
06779336190
In Commercial Distribution

  • 04015630934416 ()
06779336190

  • Vancomycin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry

ONLINE TDM Vancomyin Gen.3 - 04015630934447

No Description
Roche Diagnostics GmbH
06779344190
In Commercial Distribution

  • 04015630934447 ()
06779344190

  • Vancomycin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry

ONLINE DAT Lysergic Acid Diethylamide - 07613336164891

No Description
Roche Diagnostics GmbH
08764778190
In Commercial Distribution

  • 07613336164891 ()
08764778190

  • Lysergic acid diethylamide (LSD)/LSD metabolite IVD, reagent

ONLINE TDM Vancomycin Gen.3 - 07613336121627

No Description
Roche Diagnostics GmbH
08058849190
Not in Commercial Distribution

  • 07613336121627 ()
08058849190

  • Vancomycin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry

ONLINE TDM Vancomycin Gen.3 - 07613336157800

No Description
Roche Diagnostics GmbH
08445605190
In Commercial Distribution

  • 07613336157800 ()
08445605190

  • Vancomycin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry

ONLINE TDM Carbamazepine Gen.4 - 07613336121108

No Description
Roche Diagnostics GmbH
08057435190
In Commercial Distribution

  • 07613336121108 ()
08057435190

  • Carbamazepine therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry

ONLINE TDM Acetaminophen Gen.2 - 07613336120934

No Description
Roche Diagnostics GmbH
08056684190
In Commercial Distribution

  • 07613336120934 ()
08056684190

  • Acetaminophen IVD, kit, spectrophotometry

SEDECAL - 08436046003293

Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography
SEDECAL
SM-IV
In Commercial Distribution

  • 08436046003293 ()
CB50

  • Mobile basic diagnostic x-ray system, analogue

SEDECAL - 08436046003286

Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography
SEDECAL
SM-IV
In Commercial Distribution

  • 08436046003286 ()
CB40

  • Mobile basic diagnostic x-ray system, analogue

SEDECAL - 08436046003279

Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography
SEDECAL
SM-IV
In Commercial Distribution

  • 08436046003279 ()
CB32

  • Mobile basic diagnostic x-ray system, analogue

SEDECAL - 08436046003262

Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography
SEDECAL
SM-IV
In Commercial Distribution

  • 08436046003262 ()
CB20

  • Mobile basic diagnostic x-ray system, analogue

SEDECAL - 08436046003095

Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography
SEDECAL
SM-V
In Commercial Distribution

  • 08436046003095 ()
BA32

  • Mobile basic diagnostic x-ray system, analogue
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