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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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Bioplate® - M3848158880

Straight Plate - Low-Profile - 4 hole - 19 mm (1), Self-Drilling Screw - 4 mm (4) [5 PK
Bioplate, Inc.
81-5888
In Commercial Distribution

  • M3848158881 ()
  • M3848158880 ()
81-5888

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
  • Craniofacial bone screw, non-bioabsorbable

Bioplate® - M3848158870

T Plate - Low-Profile - 5 hole - 15 mm (1), Self-Drilling Screw - 4 mm (5) [5 PK]
Bioplate, Inc.
81-5887
In Commercial Distribution

  • M3848158871 ()
  • M3848158870 ()
81-5887

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
  • Craniofacial bone screw, non-bioabsorbable

Bioplate® - M3848158860

Boxcar Plate - Low-Profile - 4 hole - 10 mm (1), Self-Drilling Screw - 4 mm (4) [5 PK]
Bioplate, Inc.
81-5886
In Commercial Distribution

  • M3848158861 ()
  • M3848158860 ()
81-5886

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
  • Craniofacial bone screw, non-bioabsorbable

Bioplate® - M3848158850

X Plate - Low-Profile - 6 hole - 17 mm (1), Self-Drilling Screw - 4 mm (6) [5 PK]
Bioplate, Inc.
81-5885
In Commercial Distribution

  • M3848158851 ()
  • M3848158850 ()
81-5885

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
  • Craniofacial bone screw, non-bioabsorbable

ReliaTack - 10884521726345

Violet Standard Purchase Absorable Tacks
Covidien LP
RELTACK5RSW
In Commercial Distribution

  • 20884521726342 ()
  • 10884521726345 ()


  • Endoscopic manual linear stapler

ReliaTack - 10884521726338

Violet Standard Purchase Absorable Tacks
Covidien LP
RELTACK10RSW
Not in Commercial Distribution

  • 20884521726335 ()
  • 10884521726338 ()
  • 30884521726332 ()

  • Length: 5 Millimeter


  • Endoscopic manual linear stapler

ReliaTack - 10884521202399

Articulating Reloadable Fixation Device, Violet Strand Purchase Absorbable Tacks
Covidien LP
RELTACK3X10
In Commercial Distribution

  • 40884521202390 ()
  • 10884521202399 ()

  • 5 mm, Standard;


  • Endoscopic manual linear stapler

Esteem Intraoperative System Analyzer - 00812282020610

Model 3001 ISA, Sterile Cable Pack, Sensor/Driver-to-PID
Envoy Medical Corporation
3200
In Commercial Distribution

  • 00812282020610 ()
903200-002

  • Fully-implantable middle ear implant system

Esteem® Intraoperative System Analyzer - 00812282020443

Intraoperative System Analyzer (ISA), Sterile Cable, PID to Driver
Envoy Medical Corporation
3001
In Commercial Distribution

  • 00812282020443 ()
803045-002

  • Fully-implantable middle ear implant system

Esteem® Driver - 00812282020030

Driver Model 7510, IS-1 Connector
Envoy Medical Corporation
7510
In Commercial Distribution

  • 00812282020030 ()
907510-001

  • Fully-implantable middle ear implant system
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