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 Class Implantable

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Table Paper Crepe 21"x125 ft, White
Dynarex Corporation
4487
In Commercial Distribution

  • 00616784448725 ()
  • 00616784448732 ()


  • Examination/treatment table paper
Table Paper Crepe 18"x125ft. white
Dynarex Corporation
4486
In Commercial Distribution

  • 00616784448626 ()
  • 00616784448633 ()


  • Examination/treatment table paper
Table Paper Smooth 21"x225ft. White
Dynarex Corporation
4482
In Commercial Distribution

  • 00616784448220 ()
  • 00616784448237 ()


  • Examination/treatment table paper
Table Paper Smooth 18"x225ft; white
Dynarex Corporation
4481
In Commercial Distribution

  • 00616784448121 ()
  • 00616784448138 ()


  • Examination/treatment table paper
Headrest Table Paper Smooth 14"x225 ft. white
Dynarex Corporation
4480
In Commercial Distribution

  • 00616784448022 ()
  • 00616784448039 ()


  • Examination/treatment table paper
Headrest Table Paper Smooth 8"x225ft., White
Dynarex Corporation
4479
In Commercial Distribution

  • 00616784447926 ()
  • 00616784447933 ()


  • Examination/treatment table paper
COVER, PROTECTIVE, SHORT SHIELD PAD
DOMICO MED-DEVICE, LLC
9109
In Commercial Distribution

  • 00810050242691 ()
  • 10810050242698 ()


  • Medical cushion cover
COVER, PROTECTIVE, LONG SHIELD PAD
DOMICO MED-DEVICE, LLC
9110
In Commercial Distribution

  • 00810050242684 ()
  • 10810050242681 ()


  • Medical cushion cover
COVER, PROTECTIVE, AQUILLION ONE PAD
DOMICO MED-DEVICE, LLC
9111
In Commercial Distribution

  • 00810050242660 ()
  • 10810050242667 ()


  • Medical cushion cover
Protective Table Cover
DOMICO MED-DEVICE, LLC
9072
Not in Commercial Distribution

  • 00810050244848 ()
  • 10810050244845 ()


  • Medical cushion cover
COVER, PROTECTIVE, FOOT EXTENSION PAD
DOMICO MED-DEVICE, LLC
9112
In Commercial Distribution

  • 00810050242677 ()
  • 10810050242674 ()


  • Medical cushion cover
COVER, PROTECTIVE, 31.00 X 93.75
DOMICO MED-DEVICE, LLC
9032
In Commercial Distribution

  • 00810050242653 ()
  • 10810050242650 ()

  • Width: 31.00 Inch
  • Length: 93.75 Inch


  • Medical cushion cover
COVER, PROTECTIVE, 31.00 X 86.00
DOMICO MED-DEVICE, LLC
9002
In Commercial Distribution

  • 00810050242646 ()
  • 10810050242643 ()

  • Width: 31 Inch
  • Length: 86 Inch


  • Medical cushion cover
COVER, PROTECTIVE, 31.00 X 81.55
DOMICO MED-DEVICE, LLC
9033
In Commercial Distribution

  • 00810050242639 ()
  • 10810050242636 ()

  • Width: 31.00 Inch
  • Length: 81.55 Inch


  • Medical cushion cover
COVER, PROTECTIVE, 25.50 X 92.00
DOMICO MED-DEVICE, LLC
9059
In Commercial Distribution

  • 00810050242622 ()
  • 10810050242629 ()

  • Width: 25.50 Inch
  • Length: 92 Inch


  • Medical cushion cover
Pressure PreventionLTC and Hospice Product Description: Fall Mat 72 x 30 x 2in ,1/ea
Drive Devilbiss Healthcare
14700
In Commercial Distribution

  • 00822383291666 ()


  • Alternating-pressure bed mattress overlay, reusable
  • Alternating-pressure bed mattress overlay system
  • Alternating-pressure inflator
COVER ONLY FOR 9410 TABLE PAD
DOMICO MED-DEVICE, LLC
9410-C
In Commercial Distribution

  • 00810050241151 ()


  • Medical cushion cover
COVER ONLY FOR 9409 TABLE PAD
DOMICO MED-DEVICE, LLC
9409-C
In Commercial Distribution

  • 00810050241144 ()


  • Medical cushion cover
COVER, PROTECTIVE, 25.50 X 103.00
DOMICO MED-DEVICE, LLC
9060
In Commercial Distribution

  • 00810050242615 ()
  • 10810050242612 ()

  • Width: 25.50 Inch
  • Length: 103 Inch


  • Medical cushion cover
No Description
Thought Technology Ltd.
SA4515
In Commercial Distribution

  • 07540191000630 ()


  • Psychophysiological biofeedback system
Navina Smart Transanal Irrigation. Bowel diary APP
Wellspect AB
75750
Not in Commercial Distribution

  • 07392532242373 ()
75750

  • Rectal irrigation system application software
Accessories
CeramTec Schweiz GmbH
301291
In Commercial Distribution

  • 07640161395015 ()
301291

  • Dental implant suprastructure, temporary, preformed, single-use
Navina Smart Transanal Irrigation. Bowel diary APP
Wellspect AB
75750
In Commercial Distribution

75750

  • Rectal irrigation system application software
A native iOS and Android mobile application also compatible with iPad. It is used to: • Locate patients according to patient ID • Locate scheduled procedures by connecting to modality worklist • Capture videos, images and audio files to be included in the study case. • Add notes and tags to each file (asset). • Upload any file to the Orpheus System • Manually or automatically delete files from the file library
ORPHEUS MEDICAL LTD
01
In Commercial Distribution

  • 07290017025100 ()
MLL-EG30001

  • Radiology information system application software
No Description
Philips Ultrasound LLC
795160
In Commercial Distribution

  • 00884838103399 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
Eversense NOW Remote Monitoring mobile application (iOS) is intended to be a secondary device used to remotely view an Eversense CGM System user’s glucose information.
SENSEONICS, INCORPORATED
FG-5901-01-300
In Commercial Distribution

  • 00817491021267 ()
FG-5901-01-300

  • Implantable glucose monitoring system
The Wavely Middle Ear Fluid Scanner utilizes the WavelyDx Middle Ear Fluid CMD iOS Application, the mobile software, used in conjunction with the Wavely Ear Tip. The Wavely Middle Ear Fluid Scanner turns a smartphone into an acoustic reflectometer, which uses sound waves to accurately detect the presence of middle ear fluid that may be associated with acute ear infection.
Wavely Diagnostics, Inc.
SWA-1262
In Commercial Distribution

  • 00860007953712 ()
SWA-1262

  • Impedance audiometer
reSET-O® Mobile Application running on iOS. reSET-O is a prescription-only digital therapy intended to deliver cognitive behavioral therapy (CBT) to patients with opioid use disorder (OUD). The Demo Version provides demonstration access to various prescription versions of the reSET-O product and is not intended for patients.
PEAR THERAPEUTICS, INC.
1
In Commercial Distribution

  • 10851580008231 ()


  • Mental health/function therapeutic software, screen-viewed
reSET® Mobile Application running on iOS. reSET is a prescription-only digital therapy intended to deliver cognitive behavioral therapy (CBT) to patients with substance use disorder (SUD). The Demo Version provides demonstration access to various prescription versions of the reSET product and is not intended for patients.
PEAR THERAPEUTICS, INC.
1
In Commercial Distribution

  • 10851580008200 ()


  • Mental health/function therapeutic software, screen-viewed
Accessories
CeramTec Schweiz GmbH
301251
In Commercial Distribution

  • 07640161394780 ()
301251

  • Dental implant suprastructure, temporary, preformed, single-use
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