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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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EVA SELECT - D83399924122000

EVA SELECT SIZE 2 SYSTEM
ImageWorks
9992412200
In Commercial Distribution

  • D83399924122000 ()
9992412200

  • General-purpose dental x-ray system application software
  • Dental digital imaging sensor, intraoral

EVA SELECT - D83399924121000

EVA SELECT SIZE 1 SYSTEM
ImageWorks
9992412100
In Commercial Distribution

  • D83399924121000 ()
9992412100

  • Dental digital imaging sensor, intraoral
  • General-purpose dental x-ray system application software

WVSM Wireless Vital Signs Monitor - B3945000001120

Wireless Patient Monitor
ATHENA GTX, INC.
WVSM 5.0
In Commercial Distribution

  • B3945000001120 ()
500-0001-12

  • Multiple vital physiological parameter monitoring system, clinical
  • Multiple-patient intensive/general healthcare physiologic monitoring system

WVSM Wireless Vital Signs Monitor - B3945000001010

Wireless Patient Monitor
ATHENA GTX, INC.
WVSM 5.0
In Commercial Distribution

  • B3945000001010 ()
500-0001-01

  • Multiple-patient intensive/general healthcare physiologic monitoring system
  • Multiple vital physiological parameter monitoring system, clinical

Penumbra Coil 400 - 00815948025103

Coil 400 Standard, 15mm x 45cm
PENUMBRA, INC.
4002C1545-A
In Commercial Distribution

  • 00815948025103 ()
4002C1545

  • Neurovascular embolization coil
  • Surgical microscope video camera, sterilizable

Welch Allyn, Inc. - 00732094264999

E-Scribe ECG Data Management Workstation - Rx system, floating; English system language; 220V power; Tower workstation computer hardware (no keyboard, mouse, or display); 19 in. display monitor
WELCH ALLYN, INC.
901134
In Commercial Distribution

  • 00732094264999 ()
ESWKST-FAB-AAXXX

  • Patient health record information system application software

PATRAN Slide Sheets - 00850050415169

PATRAN® dispensers, holds one box of any style PATRAN® slide sheets, 11”W x 9.5”L x 4”D, mounting hardware included. Made of PET.
Jamar Health Products, Inc.
9622 Dispenser
In Commercial Distribution

  • 00850050415176 ()
  • 00850050415169 ()


  • Patient transfer sliding mat

Welch Allyn, Inc. - 00732094265064

E-Scribe ECG Data Management Workstation - Enterprise system, floating; English system language; 110V power; Tower workstation computer hardware (no keyboard, mouse, or display); 24 in. widescreen display monitor
WELCH ALLYN, INC.
901134
In Commercial Distribution

  • 00732094265064 ()
ESWKST-DAA-ABXXX

  • Patient health record information system application software

Alinity c ACE Assay File - 08058056685445

The Alinity c ACE Assay File is an accessory intended to be used for driving and influencing the use of the Alinity c system automated analyser hardware.
SENTINEL CH. SPA
06U86-1A
In Commercial Distribution

  • 08058056685445 ()
06U86-1A

  • Laboratory instrument/analyser application software IVD

ARCHITECT c ACE Assay File - 08058056685438

The ARCHITECT c ACE Assay File is an accessory intended to be used for driving and influencing the use of the ARCHITECT c systems automated analyser hardware.
SENTINEL CH. SPA
6U82-1A
In Commercial Distribution

  • 08058056685438 ()
6U82-1A

  • Laboratory instrument/analyser application software IVD
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