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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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No Description
CLEAR GUIDE MEDICAL, INC.
CGTT
In Commercial Distribution

  • B201CGTT1 ()
  • B201CGTT0 ()
  • B201CGTT2 ()


  • Imaging lesion localization marker, external, single-use
  • Surgical optical-tracking spatial marker, single-use
The device is a sterile accessory intended to provide a sterile barrier for medical procedures that require sterility and utilize the Clear Guide SuperPROBE (customer's ultrasound probe with Clear Guide Optical Head). The device is intended to be used in clinical settings, by clinicians familiar with aseptic technique. Device is packaged together with one sterile gel packet.
CLEAR GUIDE MEDICAL, INC.
CGSMM
In Commercial Distribution

  • B201CGSMM0 ()
  • B201CGSMM1 ()
  • B201CGSMM2 ()
CG-SM-M

  • Optical medical device procedural cover
  • Intraoperative ultrasound imaging transducer cover
Disposable Bipolar Cord Straight 12 FT
STINGRAY SURGICAL PRODUCTS, LLC
S04-800
Not in Commercial Distribution

  • B112S048000 ()
  • B112S048001 ()
  • B112S048002 ()


  • Electrical-only medical device connection cable, single-use
Surgical Nerve Stimulator/Locator
Checkpoint Surgical, Inc.
9394
In Commercial Distribution

  • B13093941 ()
  • B13093942 ()
  • B13093943 ()


  • Nerve-locating system
Surgical Nerve Stimulator/Locator
Checkpoint Surgical, Inc.
9094
In Commercial Distribution

  • B13090941 ()
  • B13090942 ()
  • B13090943 ()


  • Nerve-locating system
No Description
MEDITECH SPINE, LLC
S1-9-42460-60
In Commercial Distribution

  • B167S4942460602 ()
  • B167S2942460601 ()
  • B167S1942460600 ()


  • Spinal bone screw, non-bioabsorbable
No Description
MEDITECH SPINE, LLC
S1-9-42460-55
In Commercial Distribution

  • B167S4942460552 ()
  • B167S2942460551 ()
  • B167S1942460550 ()


  • Spinal bone screw, non-bioabsorbable
No Description
MEDITECH SPINE, LLC
S1-9-42460-50
In Commercial Distribution

  • B167S2942460501 ()
  • B167S4942460502 ()
  • B167S1942460500 ()


  • Spinal bone screw, non-bioabsorbable
No Description
MEDITECH SPINE, LLC
S1-9-42460-45
In Commercial Distribution

  • B167S4942460452 ()
  • B167S2942460451 ()
  • B167S1942460450 ()


  • Spinal bone screw, non-bioabsorbable
No Description
MEDITECH SPINE, LLC
S1-9-42460-40
In Commercial Distribution

  • B167S4942460402 ()
  • B167S2942460401 ()
  • B167S1942460400 ()


  • Spinal bone screw, non-bioabsorbable
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