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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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Cortera - 00810076567808

Screw, Poly, CC Cann, 4.5x105
Surgalign Spine Technologies, Inc.
150103-45105
In Commercial Distribution

  • 00810076567808 ()


  • Bone-screw internal spinal fixation system, non-sterile

Cortera - 00810076567792

Screw, Poly, CC Cann, 4.5x100
Surgalign Spine Technologies, Inc.
150103-45100
In Commercial Distribution

  • 00810076567792 ()


  • Bone-screw internal spinal fixation system, non-sterile

Cortera - 00810076567785

Screw, Poly, CC Cann, 4.5x95
Surgalign Spine Technologies, Inc.
150103-45095
In Commercial Distribution

  • 00810076567785 ()


  • Bone-screw internal spinal fixation system, non-sterile

Oticon - 05707131268563

STRPR 1.2 APP, LINKED BL STREAMER PRO 1.2 NO LOGO
Oticon A/S
139346
In Commercial Distribution

  • 05707131268563 ()


  • Hearing aid neck induction loop, wireless input

Oticon - 05707131268549

STRPR 1.2 APP, LINKED WH STREAMER PRO 1.2 NO LOGO
Oticon A/S
139342
In Commercial Distribution

  • 05707131268549 ()


  • Hearing aid neck induction loop, wireless input

Flo - 05060630101497

MEGA-AMZ-TAMP-1 - FLO Organic Cotton App Tampons Regular Pack (80 Tampons)
HERE WE FLO LTD
MEGA-AMZ-TAMP-1
In Commercial Distribution

  • 05060630101497 ()


  • Menstrual tampon, unscented

Med Aire - 00822383536323

Med Aire Assure 5" Air + 3" Foam APP and LAL
Drive Devilbiss Healthcare
14530
In Commercial Distribution

  • 00822383536323 ()


  • Alternating-pressure bed mattress overlay, reusable
  • Alternating-pressure inflator
  • Alternating-pressure bed mattress overlay system

Marina Medical - 00840306836374

Wireless Endoscopic Camera System with Wifi, 1080p, Endovision App, White
MARINA MEDICAL INSTRUMENTS, INC.
350-525
In Commercial Distribution

  • 00840306836374 ()
350-525

  • Endoscope video camera

FIBRIJET - 00815634020085

SPRAY SET ENDOSCOPIC APP. 5MM, 40 CM, 1:1 RATIO
Micromedics, Inc.
SA-3655
In Commercial Distribution

  • 00815634020085 ()
  • 10815634020082 ()
  • 20815634020089 ()


  • Open-surgery adhesive/sealant applicator, dual-channel

Cora - 00810042480568

Cora Tampons, DTC, App. Light 5/Reg. 6/Super 5
Cora
02Tampons-105
In Commercial Distribution

  • 00850373007041 ()
  • 00810042480568 ()


  • Menstrual tampon, unscented
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