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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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ORTHOSOURCE - D9115574670

Blue Etch 60 ml syringe
ORTHOSOURCE
557-467
In Commercial Distribution

  • D9115574670 ()
  • D911557467601 ()


  • Dental etching solution

ORTHOSOURCE - D9115574660

Green Etch 60 ml syringe
ORTHOSOURCE
557-466
In Commercial Distribution

  • D911557466601 ()
  • D9115574660 ()


  • Dental etching solution

ORTHOSOURCE - D9115574680

Red Etch 60 ml syringe
ORTHOSOURCE
557-468
In Commercial Distribution

  • D911557468601 ()
  • D9115574680 ()


  • Dental etching solution

ATRAMAT - 07500142029769

ATRAMAT PGC25 SURGICAL SUTURE VIOLET USP 3-0 EP 2, 70 CM NEEDLE SG-36 PREMIUM HEAVY TAPER POINT 36 MM 1/2 CIRCLE 36 UNITS
Internacional Farmacéutica, S.A. de C.V.
PGC25
In Commercial Distribution

  • 07500142329760 ()
  • 07500142029769 ()

  • Length: 36 Millimeter
  • USP 3-0 EP 2
SG3603-H

  • Polyester suture, bioabsorbable, monofilament, non-antimicrobial

ATRAMAT - 07500142005046

ATRAMAT POLYESTER SURGICAL SUTURE GREEN USP 2-0 EP 3, 75 CM DOUBLE NEEDLE S-16 PREMIUM TAPER POINT 16 MM 1/2 CIRCLE KIT WITH PLEDGET WITH 6 POUCHES
Internacional Farmacéutica, S.A. de C.V.
POLYESTER
In Commercial Distribution

  • 07500142905049 ()
  • 07500142005046 ()

  • Length: 16 Millimeter
  • USP 2-0 EP 3
S1652/2-75KP6

  • Polyester suture, non-bioabsorbable, multifilament

FaceLake - 00851908007062

The 50EW is a rechargeable pulse oximeter that is designed to accurately measure oxygen saturation (SpO2) and pulse rate through your finger.
LORTE TECHNOLOGIES, INC
CMS-50EW with Bluetooth
In Commercial Distribution

  • 00851908007062 ()


  • Pulse oximeter

Shower Seat - 05707581000751

No Description
Ropox A/S
Foldable, with leg
In Commercial Distribution

  • 05707581000751 ()
40-43011-2

  • Shower seat, non-powered

zuvo - 00850041729084

zuvo 16 with eyespeak, speech generating device
Talk To ME Technologies, LLC
16 with eyespeak
In Commercial Distribution

  • 00850041729084 ()


  • Voice synthesizer/digitizer

zuvo - 00850041729077

zuvo 12 with eyespeak, speech generating device
Talk To ME Technologies, LLC
12 with eyespeak
In Commercial Distribution

  • 00850041729077 ()


  • Voice synthesizer/digitizer

Prosomnus IA MicrO2 with Patient Monitoring - 00863039000447

Obstructive Sleep Apnea Device with twin mated posts and Patient Monitoring
PROSOMNUS SLEEP TECHNOLOGIES
MicrO2 with Monitoring
In Commercial Distribution

  • 00863039000447 ()


  • Mandible-repositioning sleep-disordered breathing orthosis
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