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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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Final Orthog Surgical Splint Digital
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860012759408 ()
FFCOD

  • Custom-made orthopaedic/craniofacial surgical guide
The GI Windows Titanium Grasper is a surgical laparoscopic grasper with a non-ferrous distal actuator that is intended to be used with GIW’s Self-Forming Magnet (SFM) technology. The grasper’s form factor, handle, length, and actuation will be nearly identical to commercially available laparoscopic graspers that we used every day in the operating room. The primary differentiator of this product will be the titanium distal actuator, which due to its non-ferrous make up, will not create (or minimally create) a magnetic attraction force to the SFM implants while in use in surgery.
G.I. Windows, Inc.
200123
In Commercial Distribution

  • 00860012315505 ()


  • Surgical soft-tissue manipulation forceps, scissors-like, reusable
Healing Abutment - Wide Ø 6.0 H 3.0
IMPLANT CLUB, INC
1
In Commercial Distribution

  • 00860012237357 ()
EVHA63

  • Dental implant system
Healing Abutment - Tall Ø 5.0 H 5.0
IMPLANT CLUB, INC
1
In Commercial Distribution

  • 00860012237340 ()
EVHA55

  • Dental implant system
Healing Abutment - Regular Ø 5.0 H 3.0
IMPLANT CLUB, INC
1
In Commercial Distribution

  • 00860012237333 ()
EVHA53

  • Dental implant system
Healing Abutment - Skinny Ø 4.0 H 3.0
IMPLANT CLUB, INC
1
In Commercial Distribution

  • 00860012237326 ()
EVHA43

  • Dental implant system
Closed Tray Impression Coping Straight Transfer Abutment L - 2mm
IMPLANT CLUB, INC
1
In Commercial Distribution

  • 00860012237319 ()


  • Dental implant suprastructure, temporary, preformed, single-use
Open Tray Impression Coping Standard Open Transfer 13mm
IMPLANT CLUB, INC
1
In Commercial Distribution

  • 00860012237302 ()
ST13

  • Dental implant suprastructure, temporary, preformed, single-use
Neuromuscular transmission (NMT) monitor for monitoring the neuromuscular block of a patient in the operating theatre, recovery room or intensive care unit.
NERBIO PRIVATE LIMITED
ITOFDEV01
In Commercial Distribution

  • 00860012119660 ()
  • 00860012119677 ()


  • Block-monitoring peripheral nerve electrical stimulation system
The RedDrop One is a single-use blood lancing device intended for producing microliter capillary whole blood samples. It does not collect or transport such samples.
REDDROP DX, INC.
300-25-007
In Commercial Distribution

  • 00860011954002 ()
  • 00860011954033 ()
  • 00860011954026 ()
  • 00860011954019 ()


  • Manual blood lancing device, single-use
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