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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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No Description
TALLADIUM, INC.
19820-OFAML-D3
In Commercial Distribution

  • D79119820OFAMLD30 ()
19820-OFAML-D3

  • Dental appliance fabrication material, ceramic
No Description
TALLADIUM, INC.
19820-ATML-B1
In Commercial Distribution

  • D79119820ATMLB10 ()
19820-ATML-B1

  • Dental appliance fabrication material, ceramic
InTENSity at Home OTC TENS device with 12 preset programs and 100 Intensity levels
COMPASS HEALTH BRANDS CORP.
E200-6R
In Commercial Distribution

  • 30092237619590 ()
  • 00092237619599 ()
  • 80092237619595 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
Inogen At Home Stationary Concentrator, CE (10-06316-XX-XX)
Inogen, Inc.
CE
In Commercial Distribution

  • 00817131020148 ()
GS-100

  • Stationary oxygen concentrator
Inogen At Home Stationary Concentrator, NCE (10-05345-XX-XX)
Inogen, Inc.
NCE
In Commercial Distribution

  • 00817131020131 ()
GS-100

  • Stationary oxygen concentrator
ACTIVATOR 9465AA PATIENT ACTIVATOR US
MEDTRONIC, INC.
9465AA
Not in Commercial Distribution

  • 00721902825569 ()


  • Cardiac pulse generator reader, home-use
No Description
ALIMED, INC.
1431
In Commercial Distribution

  • 00733657216899 ()
2970000240

  • Gel-filled chair cushion
The Minuteful for Wound device is a comprehensive wound management system designed to assist in the management of chronic wounds. It is intended to support healthcare professionals in the clinical assessment of wounds by measuring, documenting, monitoring, and managing information relevant to the progression and treatment of chronic wounds. The device comprises Calibration Stickers, a Web Portal for healthcare professionals to review and manage wound data, and two separate smartphone applications. These applications are utilized for the collection of wound data: one for healthcare professionals and one for lay users under the guidance and supervision of healthcare professionals.
HEALTHY.IO LTD
WND PNT.EN.GEN
In Commercial Distribution

  • 07290017272504 ()
  • 17290017272877 ()


  • Wound management image-analysis software
Surgical Gown, Level 3, grippers at neck, tie at waist, special color coded neckband, Size 4XL
Lac-Mac Limited
005XXCE-4XL
In Commercial Distribution

  • 00627755581150 ()

  • Height: 59.25 Inch
005XXCE-4XL

  • Surgical gown, reusable
Surgical Gown, Level 4, grippers at neck, tie at waist, special color coded neckband, Size 4XL
Lac-Mac Limited
005XXBN-4XL
In Commercial Distribution

  • 00627755581143 ()

  • Height: 59.25 Inch
005XXBN-4XL

  • Surgical gown, reusable
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