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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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Freudenberg Medical, LLC
IN 1620-NS
In Commercial Distribution

  • 00813307011149 ()


  • Airway device cleaning utensil, invasive
  • Tracheoesophageal speech valve, indwelling, non-sterile
  • Tracheoesophageal speech valve irrigation device
  • Tracheoesophageal device insertion capsule
  • Tracheoesophageal device introducer
No Description
Freudenberg Medical, LLC
IN 1618-NS
In Commercial Distribution

  • 00813307011132 ()


  • Tracheoesophageal device introducer
  • Tracheoesophageal device insertion capsule
  • Tracheoesophageal speech valve irrigation device
  • Tracheoesophageal speech valve, indwelling, non-sterile
  • Airway device cleaning utensil, invasive
Kit Contains: C0R47, 12x100 Kii BALLOON BLUNT TIP 6/BX CTF03, 5x100 Kii Fios Z-THR 6/BX CTF33, 11x100 Kii Fios ZTHR 6/BX C4130, 5mmx35cm EPIX LAPA GRASPER, 10/BX CB030, 5mmx35cm EPIX LAPA SCISSOR, 10/BX CA090, DIRECT DRIVE LCA 3/BX CD001, 10mm RETRIEVAL SYSTEM, 10/BX
APPLIED MEDICAL RESOURCES CORPORATION
GK209
In Commercial Distribution

  • 20607915129365 ()


  • Tissue extraction bag
  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
  • Rigid endoscopic grasping forceps, single-use
  • Laparoscopic access cannula, single-use
  • Ligation clip, metallic
Kit Contains: CTS02, 5x100 Kii® SLEEVE ZTHR 12/BX CD003, 5mm RETRIEVAL SYSTEM, 10/BX CA500, EPIX® UNIVERSAL CLIP APPLIER 3/BX CFF12, 5x100 Kii® Fios® ADVFIX DP 10/BX CB030, 5mmx35cm EPIX® LAPA SCISSOR, 10/BX CFS02, 5x100 Kii® SLEEVE ADVFIX 12/BX C4130, 5mmx35cm EPIX® LAPA GRASPER, 10/BX
APPLIED MEDICAL RESOURCES CORPORATION
K2260
In Commercial Distribution

  • 30607915128242 ()


  • Tissue extraction bag
  • Rigid endoscopic grasping forceps, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
  • Laparoscopic access cannula, single-use
  • Ligation clip, metallic
The SYNSTER CERVICAL CAGE are indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.
BM KOREA CO., LTD
TT1535
In Commercial Distribution

  • 08809255541472 ()

  • Length: 35 Millimeter
  • Height: 15 Millimeter


  • Metallic spinal fusion cage, non-sterile
The SYNSTER CERVICAL CAGE are indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.
BM KOREA CO., LTD
TT1435
In Commercial Distribution

  • 08809255541465 ()

  • Length: 35 Millimeter
  • Height: 14 Millimeter


  • Metallic spinal fusion cage, non-sterile
The SYNSTER CERVICAL CAGE are indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.
BM KOREA CO., LTD
TT1335
In Commercial Distribution

  • 08809255541458 ()

  • Length: 35 Millimeter
  • Height: 13 Millimeter


  • Metallic spinal fusion cage, non-sterile
The SYNSTER CERVICAL CAGE are indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.
BM KOREA CO., LTD
TT1235
In Commercial Distribution

  • 08809255541441 ()

  • Length: 35 Millimeter
  • Height: 12 Millimeter


  • Metallic spinal fusion cage, non-sterile
The SYNSTER CERVICAL CAGE are indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.
BM KOREA CO., LTD
TT1135
In Commercial Distribution

  • 08809255541434 ()

  • Length: 35 Millimeter
  • Height: 11 Millimeter


  • Metallic spinal fusion cage, non-sterile
The SYNSTER CERVICAL CAGE are indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.
BM KOREA CO., LTD
TT1035
In Commercial Distribution

  • 08809255541427 ()

  • Length: 35 Millimeter
  • Height: 10 Millimeter


  • Metallic spinal fusion cage, non-sterile
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