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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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WAHTS - 00860005068302

No Description
WAHTS HEARING LLC
AC 1
In Commercial Distribution

  • 00860005068302 ()


  • Tone audiometer

MONOPOWER NITRILE GLOVES POWDER FREE - 00860005054411

Non-Sterile/ Powder Free Ambidextrous Finger Tip Textured Beaded cuff Single use only
MONOPOWER BIOPHARMACEUTICALS COMPANY LIMITED
1
In Commercial Distribution

  • 00860005054411 ()
  • 08600050544114 ()


  • Surgical/examination garment kit

EasyBoost SPU Zipper Sheet with Side Handles - 00860004936879

Case of 12 Sheets with zipper and side handles for in-bed repositioning, Polyester fabric, 66" x 108"
Seneca Devices, Inc.
ESB-DIS-2027
In Commercial Distribution

  • 00860004936879 ()
  • 10860004936876 ()


  • Patient transfer/turning sheet, single-use

EasyShift Sheet - 00860004936862

EasyShift SPU Zipper Sheet
Seneca Devices, Inc.
EAS-Z-SPU
In Commercial Distribution

  • 10860004936869 ()
  • 00860004936862 ()


  • Patient transfer/turning sheet, single-use

EasyBoost - 00860004936855

EasyBoost Repositioning System V1 Compatible with EasyBoost Zipper Sheet
Seneca Devices, Inc.
ESB-Z
In Commercial Distribution

  • 00860004936855 ()


  • Electrical assistive bed

EasyBoost - 00860004936831

EasyBoost repositioning system compatible with HoverMatt.
Seneca Devices, Inc.
ESB-HM
In Commercial Distribution

  • 00860004936831 ()


  • Electrical assistive bed

EasyBoost 400 - 00860004936824

Air blower unit (with hook) for use with EasyBoost Cushion, for safe working load up to 400 lbs
Seneca Devices, Inc.
ESB-400H
In Commercial Distribution

  • 00860004936824 ()


  • Electrical assistive bed

ScarMD - 00860004589785

ScarMD Silicone Scar Gel 6g Glide
AIM MEDICAL INC.
6g Glide
In Commercial Distribution

  • 00860004589785 ()


  • Scar-management dressing, single-use

ANNE Pediatric - 00860004541721

ANNE Pediatric is a wireless vital signs monitoring platform for use on neonatal patients of any gestational age up to infants 2 years of age.
Sibel Health Inc.
SA-011
In Commercial Distribution

  • 00860004541721 ()


  • Wearable multiple physiological parameter recorder, reusable

ANNE Sleep - 00860004541714

ANNE Sleep is a wearable sensor system intended for use in the collection, analysis, display, and storage of physiological parameters to aid in the diagnosis of sleep-related breathing disorders by healthcare professionals.
Sibel Health Inc.
SA-008
In Commercial Distribution

  • 00860004541714 ()


  • Wearable multiple physiological parameter recorder, reusable
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