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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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One Piece O-Ball Dental Implant: 4.0mm Diameter X 14mm length
OCO BIOMEDICAL INC
O-Ball
In Commercial Distribution

  • D785ISI4014OB0 ()
ISI 4014 OB

  • Screw endosteal dental implant, one-piece
Manometer, Aneroid, One Hand, 0-300 mmHg w/Valve and Bulb
ANESTHESIA ASSOCIATES, INC.
00-496
In Commercial Distribution

  • B005004960 ()
00-496

  • Blood pressure cuff, reusable
Set of one Kneefix cushion and two Knee Elevation Blocks
Klarity Medical Products, LLC
R634-12E
In Commercial Distribution

  • 00817355023499 ()


  • Indexed-immobilization patient positioning system
545TPU WAFFLE CUSTOM EXTENDED CARE HEEL ELEVATOR - ONE SIZE - SNGL
EHOB INC
REV00
In Commercial Distribution

  • 30603354300492 ()
  • 10603354300146 ()
5450TPUX010

  • Heel protector
One SafetyO2 Kit Non-rebreather Oxygen Mask with FacePlate and Tubing
GROMAN INC.
AM-OXY-FP
In Commercial Distribution

  • 10817494020707 ()
  • 00817494020700 ()
  • 20817494020704 ()
  • 30817494020701 ()


  • Non-rebreathing oxygen face mask
One Kit of SafetyNeb Mask with FacePlate and Nebulizer Tubing
GROMAN INC.
AM-NEB-FP
In Commercial Distribution

  • 10817494020691 ()
  • 00817494020694 ()
  • 20817494020698 ()
  • 30817494020695 ()


  • Aerosol face mask, rebreathing, single-use
Pouch contains one Eversense 365 Sensor in a Sensor holder.
SENSEONICS, INCORPORATED
102606-023
In Commercial Distribution

  • 00817491024220 ()


  • Implantable glucose monitoring system sensor
Eversense Pouch contains one Eversense Sensor in a Sensor holder.
SENSEONICS, INCORPORATED
102095-67A
Not in Commercial Distribution

  • 00817491022363 ()
N/A

  • Implantable glucose monitoring system sensor
Eversense Pouch contains one Eversense Sensor in a Sensor holder.
SENSEONICS, INCORPORATED
102095-67A
Not in Commercial Distribution

  • 00817491021434 ()
N/A

  • Implantable glucose monitoring system sensor
LIF AMP, ONE SCREW PLATE, 11 AND CENTER SCREW, 20MM
ALPHATEC SPINE, INC.
116-1-5-11-S
In Commercial Distribution

  • 00190376282879 ()


  • Spinal fixation plate, non-bioabsorbable
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