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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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PLANNING STATION-ROSA ONE- USA - 03760244034922

planning station DELL 3560 Querty power plug B for Rosa One 3.1.6
MEDTECH
164050
In Commercial Distribution

  • 03760244034922 ()
ROSAS00503

  • Multi-purpose stereotactic surgery system

PLANNING STATION Rosa One -USA - 03760244034403

planning station DELL 7520 Querty power plug B for Rosa One 3.1.5 (Brain application)
MEDTECH
164017
In Commercial Distribution

  • 03760244034403 ()
ROSAS00503

  • Multi-purpose stereotactic surgery system

PLANNING STATION Rosa One - 03760244033840

planning station DELL 7520 Querty power plug B for Rosa One 3.1.4.0
MEDTECH
164017
In Commercial Distribution

  • 03760244033840 ()
ROSAS00503

  • Multi-purpose stereotactic surgery system

PLANNING STATION Rosa One - 03760244032652

planning station DELL 7520 Querty power plug B for Rosa One 3.1.1.0
MEDTECH
164017-00
Not in Commercial Distribution

  • 03760244032652 ()
ROSAS00503

  • Multi-purpose stereotactic surgery system

ROSA PLANNING STATION - 03760244030375

ROSA PLANNING STATION Laptop computer with the following minimal configuration : Windows 7, intel Pentium processor, 15,6'' screen, DVD +/- RW, USB ports, 25GB graphics card, eternet connection for PACS interface with graphical user interface for surgical planning, pre-operative navigation and frameless streotaxy.
MEDTECH
DELL 7520
Not in Commercial Distribution

  • 03760244030375 ()
ROSAS00369

  • Multi-purpose stereotactic surgery system
  • Neurological stereotactic surgery system

Vapotherm - 00841737105831

HVT 2.0 Buy Out Unit
VAPOTHERM, INC.
HVT-BUYOUT
In Commercial Distribution

  • 00841737105831 ()


  • Electrical mains power cable
  • Respiratory oxygen sensor
  • Professional high-flow respiratory unit, humidifying, manual

Young - 00302730591002

Young Pointed Polisher, Soft, Gray, Ribbed Exterior, Screw Type, Bulk Buy
YOUNG DENTAL MANUFACTURING I, LLC
059100
In Commercial Distribution

  • 10302730591009 ()
  • 00302730591002 ()
059100

  • Dental polishing cup, single-use

Young - 00302730547009

Young Petite Web Prophy Cup, Latex Free, Firm, Short, Blue Web Cup, Screw Type, Bulk Buy
YOUNG DENTAL MANUFACTURING I, LLC
054700
In Commercial Distribution

  • 10302730547006 ()
  • 00302730547009 ()
054700

  • Dental polishing cup, single-use

Young - 00302730546002

Young Petite Web Prophy Cup, Latex Free, Soft, Short, Purple Web Cup, Screw Type, Bulk Buy
YOUNG DENTAL MANUFACTURING I, LLC
054600
In Commercial Distribution

  • 10302730546009 ()
  • 00302730546002 ()
054600

  • Dental polishing cup, single-use

Young - 00302730542004

Young Prophy Cup, Latex Free, Firm, Long, Blue Web Cup, Screw Type, Bulk Buy
YOUNG DENTAL MANUFACTURING I, LLC
054200
In Commercial Distribution

  • 10302730542001 ()
  • 00302730542004 ()
054200

  • Dental polishing cup, single-use

Young - 00302730538007

Young Prophy Cup, Latex Free, Firm, Long, Blue Spiraled Turbo Plus Cup, Screw Type, Bulk Buy
YOUNG DENTAL MANUFACTURING I, LLC
053800
In Commercial Distribution

  • 10302730538004 ()
  • 00302730538007 ()
053800

  • Dental polishing cup, single-use

Young - 00302730536003

Young Prophy Cup, Latex Free, Soft, Long, Purple Spiraled Turbo Plus Cup, Screw Type, Bulk Buy
YOUNG DENTAL MANUFACTURING I, LLC
053600
In Commercial Distribution

  • 10302730536000 ()
  • 00302730536003 ()
053600

  • Dental polishing cup, single-use

Young - 00302730533002

Young Prophy Cup, Firm, Long, White Spiraled Turbo Plus Cup, Screw Type, Bulk Buy
YOUNG DENTAL MANUFACTURING I, LLC
053300
In Commercial Distribution

  • 10302730533009 ()
  • 00302730533002 ()
053300

  • Dental polishing cup, single-use

Young - 00302730531008

Young Prophy Cup, Soft, Long, Gray Spiraled Turbo Plus Cup, Screw Type, Bulk Buy
YOUNG DENTAL MANUFACTURING I, LLC
053100
In Commercial Distribution

  • 10302730531005 ()
  • 00302730531008 ()
053100

  • Dental polishing cup, single-use

Young - 00302730521009

Young Prophy Cup, Soft, Long, Gray Spiraled Turbo Cup, Screw Type, Bulk Buy
YOUNG DENTAL MANUFACTURING I, LLC
052100
In Commercial Distribution

  • 10302730521006 ()
  • 00302730521009 ()
052100

  • Dental polishing cup, single-use

Young - 00302730511000

Young Prophy Cup, Soft, Long, Gray Web Cup, Screw Type, Bulk Buy
YOUNG DENTAL MANUFACTURING I, LLC
051100
In Commercial Distribution

  • 10302730511007 ()
  • 00302730511000 ()
051100

  • Dental polishing cup, single-use

Young - 00302730510003

Young Junior Prophy Cup, Soft, Long, Gray Web Cup, Screw Type, Bulk Buy
YOUNG DENTAL MANUFACTURING I, LLC
051000
In Commercial Distribution

  • 10302730510000 ()
  • 00302730510003 ()
051000

  • Dental polishing cup, single-use

Young - 00302730503005

Young Prophy Cup, Firm, Long, White Ribbed Cup, Screw Type, Bulk Buy
YOUNG DENTAL MANUFACTURING I, LLC
050300
In Commercial Distribution

  • 10302730503002 ()
  • 00302730503005 ()
050300

  • Dental polishing cup, single-use

Young - 00302730501001

Young Ribbed Prophy Cup, Soft, Long, Gray Ribbed Cup, Screw type, Bulk Buy
YOUNG DENTAL MANUFACTURING I, LLC
050100
In Commercial Distribution

  • 10302730501008 ()
  • 00302730501001 ()
050100

  • Dental polishing cup, single-use

Denticator - 00302735307004

Denticator Prophy Cup, Regular Firm, Regular Size White 4-Web Cup, Metal Latch Type, Bulk Buy
YOUNG DENTAL MANUFACTURING I, LLC
530700
In Commercial Distribution

  • 10302735307001 ()
  • 00302735307004 ()
530700

  • Dental polishing cup, single-use

Young - 00302732960516

Young Elite Flex Prophy Cup, Latex Free, Extra Soft Pink Cup, Screw Type, Bulk Buy
YOUNG DENTAL MANUFACTURING I, LLC
296051
In Commercial Distribution

  • 10302732960513 ()
  • 00302732960516 ()
296051

  • Dental polishing cup, single-use

Young - 00302732960509

Young Elite Original Prophy Cup, Latex Free, Soft Purple Cup, Screw Type, Bulk Buy
YOUNG DENTAL MANUFACTURING I, LLC
296050
In Commercial Distribution

  • 10302732960506 ()
  • 00302732960509 ()
296050

  • Dental polishing cup, single-use

Young - 00302732957226

Young Pointed Polisher, Latex Free, Firm, Blue Ribbed Exterior, Screw Type, Bulk Buy
YOUNG DENTAL MANUFACTURING I, LLC
295722
In Commercial Distribution

  • 10302732957223 ()
  • 00302732957226 ()
295722

  • Dental polishing cup, single-use

Young - 00302732957042

Young Petite Prophy Cup, Latex Free, Firm, Short, Green Web Cup, Screw Type, Bulk Buy
YOUNG DENTAL MANUFACTURING I, LLC
295704
In Commercial Distribution

  • 10302732957049 ()
  • 00302732957042 ()
295704

  • Dental polishing cup, single-use

Young - 00302732954737

Young Dentek Prophy Cup, Latex Free, Soft, Regular, Gray Web Cup, Screw Type, Bulk Buy
YOUNG DENTAL MANUFACTURING I, LLC
295473
In Commercial Distribution

  • 10302732954734 ()
  • 00302732954737 ()
295473

  • Dental polishing cup, single-use

Young - 00302730923001

Young Standard Prophy Brush, Firm, Long Flat Black Brush, Metal Latch Type, Bulk Buy
YOUNG DENTAL MANUFACTURING I, LLC
092300
In Commercial Distribution

  • 10302730923008 ()
  • 00302730923001 ()
092300

  • Dental-professional prophylaxis brush, single-use

Young - 00302730907001

Young Prophy Brush, Soft, Long Flat White Nylon Brush, Screw Type, Bulk Buy
YOUNG DENTAL MANUFACTURING I, LLC
090700
In Commercial Distribution

  • 10302730907008 ()
  • 00302730907001 ()
090700

  • Dental-professional prophylaxis brush, single-use

Young - 00302730905007

Young Pointed Midget Prophy Brush, Firm, Short Pointed Black Brush, Screw Type, Bulk Buy
YOUNG DENTAL MANUFACTURING I, LLC
090500
In Commercial Distribution

  • 10302730905004 ()
  • 00302730905007 ()
090500

  • Dental-professional prophylaxis brush, single-use

Young - 00302730904000

Young Midget Prophy Brush, Firm, Short Flat Black Brush, Screw Type, Bulk Buy
YOUNG DENTAL MANUFACTURING I, LLC
090400
In Commercial Distribution

  • 10302730904007 ()
  • 00302730904000 ()
090400

  • Dental-professional prophylaxis brush, single-use

Young - 00302730902006

Young Standard Pointed Prophy Brush, Firm, Long Pointed Black Brush, Screw Type, Bulk Buy
YOUNG DENTAL MANUFACTURING I, LLC
090200
In Commercial Distribution

  • 10302730902003 ()
  • 00302730902006 ()
090200

  • Dental-professional prophylaxis brush, single-use

Young - 00302730901009

Young Standard Prophy Brush, Firm, Long Flat Black Brush, Screw Type, Bulk Buy
YOUNG DENTAL MANUFACTURING I, LLC
090100
In Commercial Distribution

  • 10302730901006 ()
  • 00302730901009 ()
090100

  • Dental-professional prophylaxis brush, single-use

DELL - 04961333240913

22" DELL LCD MONITOR
PENTAX OF AMERICA, INC.
72066
In Commercial Distribution

  • 04961333240913 ()

  • Length: 22.0 Inch


  • Endoscopic video image display unit

DELL - 04961333244614

DELL HOT PLUG HARD DRIVE 1.2 TB
PENTAX OF AMERICA, INC.
39047
In Commercial Distribution

  • 04961333244614 ()


  • Hard-disc-station computer drive

DELL - 04961333240920

MONITOR 27" DELL PC
PENTAX OF AMERICA, INC.
72067
In Commercial Distribution

  • 04961333240920 ()

  • Length: 27.0 Inch


  • Endoscopic video image display unit

CARDINAL HEALTH - 10888439679892

GENERAL LAPAROSCOPY PACK
Cardinal Health 200, LLC
SBA23CHBUY
In Commercial Distribution

  • 50888439679890 ()
  • 10888439679892 ()
SBA23CHBUY

  • Laparoscopic surgical procedure kit, non-medicated, single-use

DCTAPER - D690BUYBACK2

Competitor Inventory Buy Back Product
Ss White Burs, Inc.
NONE
In Commercial Distribution

  • D690BUYBACK2 ()
BUYBACK

  • Carbide dental bur, single-use

NA - 00841983104183

No Audio Remote Network Station with Dell OptiPlex 7460 All-In-One Computer
NIHON KOHDEN AMERICA, INC.
RNS-6804-7460
Not in Commercial Distribution

  • 00841983104183 ()
RNS-6804-7460

  • Centralized patient monitor

NA - 00841983104176

Remote Network Station with Dell OptiPlex 7460 All-In-One Computer
NIHON KOHDEN AMERICA, INC.
RNS-6803-7460
Not in Commercial Distribution

  • 00841983104176 ()
RNS-6803-7460

  • Centralized patient monitor

NEUROFAX - 00841983103971

NEUROFAX ACQUISITION, Dell Precision Tower desktop
NIHON KOHDEN AMERICA, INC.
EEG-1200A-T
In Commercial Distribution

  • 00841983103971 ()
EEG-1200A-T

  • Electroencephalograph

Sectra Digital Pathology Module - 07350092810593

For In Vitro Diagnostic Use Sectra Digital Pathology Module (3.3) is a software device intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis. Sectra Digital Pathology Module (3.3) is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Sectra Digital Pathology Module. Sectra Digital Pathology Module (3.3) is intended for use with Leica’s Aperio GT 450 DX scanner and Dell U3223QE display, for viewing and management of the ScanScope Virtual Slide (SVS) and Digital Imaging and Communications in Medicine (DICOM) image formats.
Sectra AB
4.2
In Commercial Distribution

  • 07350092810593 ()


  • Pathology information system

Sectra Digital Pathology Module - 07350092810524

For In Vitro Diagnostic Use Sectra Digital Pathology Module (3.3) is a software device intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis. Sectra Digital Pathology Module (3.3) is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Sectra Digital Pathology Module. Sectra Digital Pathology Module (3.3) is intended for use with Leica’s Aperio GT 450 DX scanner and Dell U3223QE display, for viewing and management of the ScanScope Virtual Slide (SVS) and Digital Imaging and Communications in Medicine (DICOM) image formats.
Sectra AB
4.1
In Commercial Distribution

  • 07350092810524 ()


  • Pathology information system

Sectra Digital Pathology Module - 07350092810500

For In Vitro Diagnostic Use Sectra Digital Pathology Module device is a software intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis. Sectra Digital Pathology Module is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Sectra Digital Pathology Module. Sectra Digital Pathology Module is intended for use with Leica's Aperio AT2 DX scanner and Dell MR2416 monitor.
Sectra AB
4.0
In Commercial Distribution

  • 07350092810500 ()


  • Pathology information system

Sectra Digital Pathology Module - 07350092810487

For In Vitro Diagnostic Use Sectra Digital Pathology Module device is a software intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis. Sectra Digital Pathology Module is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Sectra Digital Pathology Module. Sectra Digital Pathology Module is intended for use with Leica's Aperio AT2 DX scanner and Dell MR2416 monitor.
Sectra AB
3.4
In Commercial Distribution

  • 07350092810487 ()


  • Pathology information system

Sectra Digital Pathology Module - 07350092810456

For In Vitro Diagnostic Use Sectra Digital Pathology Module device is a software intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis. Sectra Digital Pathology Module is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Sectra Digital Pathology Module. Sectra Digital Pathology Module is intended for use with Leica's Aperio AT2 DX scanner and Dell MR2416 monitor.
Sectra AB
3.3
In Commercial Distribution

  • 07350092810456 ()


  • Pathology information system

Sectra Digital Pathology Module - 07350092810425

For In Vitro Diagnostic Use Sectra Digital Pathology Module device is a software intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis. Sectra Digital Pathology Module is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Sectra Digital Pathology Module. Sectra Digital Pathology Module is intended for use with Leica's Aperio AT2 DX scanner and Dell MR2416 monitor.
Sectra AB
3.2
In Commercial Distribution

  • 07350092810425 ()


  • Pathology information system

Sectra Digital Pathology Module - 07350092810388

For In Vitro Diagnostic Use Sectra Digital Pathology Module device is a software intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis. Sectra Digital Pathology Module is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Sectra Digital Pathology Module. Sectra Digital Pathology Module is intended for use with Leica's Aperio AT2 DX scanner and Dell MR2416 monitor.
Sectra AB
3.1
In Commercial Distribution

  • 07350092810388 ()


  • Pathology information system

Sectra Digital Pathology Module - 07350092810333

For In Vitro Diagnostic Use Sectra Digital Pathology Module device is a software intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis. Sectra Digital Pathology Module is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Sectra Digital Pathology Module. Sectra Digital Pathology Module is intended for use with Leica's Aperio AT2 DX scanner and Dell MR2416 monitor.
Sectra AB
2.5
In Commercial Distribution

  • 07350092810333 ()


  • Pathology information system

Sectra Digital Pathology Module - 07350092810289

For In Vitro Diagnostic Use Sectra Digital Pathology Module device is a software intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis. Sectra Digital Pathology Module is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Sectra Digital Pathology Module. Sectra Digital Pathology Module is intended for use with Leica's Aperio AT2 DX scanner and Dell MR2416 monitor.
Sectra AB
2.4
In Commercial Distribution

  • 07350092810289 ()


  • Pathology information system

Sectra Digital Pathology Module - 07350092810241

For In Vitro Diagnostic Use Sectra Digital Pathology Module device is a software intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis. Sectra Digital Pathology Module is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Sectra Digital Pathology Module. Sectra Digital Pathology Module is intended for use with Leica's Aperio AT2 DX scanner and Dell MR2416 monitor.
Sectra AB
2.3
In Commercial Distribution

  • 07350092810241 ()


  • Pathology information system

Sectra Digital Pathology Module - 07350092810197

For In Vitro Diagnostic Use Sectra Digital Pathology Module device is a software intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis. Sectra Digital Pathology Module is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Sectra Digital Pathology Module. Sectra Digital Pathology Module is intended for use with Leica's Aperio AT2 DX scanner and Dell MR2416 monitor.
Sectra AB
2.2
In Commercial Distribution

  • 07350092810197 ()


  • Pathology information system
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