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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® - M3848158920

Straight Plate - Low-Profile - 2 hole - 14 mm (2), Self-Drilling Screw - 4 mm (4) [5 PK]
Bioplate, Inc.
81-5892
In Commercial Distribution

  • M3848158921 ()
  • M3848158920 ()
81-5892

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

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

Blue Sky Bio, LLC - 00810060224854

Bio | Cut Guide Tube 6.9 OD x 5.9 ID x 4mm L
BLUE SKY BIO LLC
TUBE69-59-4L
In Commercial Distribution

  • 00810060224854 ()


  • Surgical torque wrench adaptor

Blue Sky Bio, LLC - 00810060224847

BIO | Cut Guide Tube 5.8 OD x 4.8 ID x 4mm L
BLUE SKY BIO LLC
TUBE58-48-4L
In Commercial Distribution

  • 00810060224847 ()


  • Surgical torque wrench adaptor

Blue Sky Bio, LLC - 00810060224830

BIO | Guide-Tube for 5mm Nob. Master 4.50mm
BLUE SKY BIO LLC
TUBE49-450
In Commercial Distribution

  • 00810060224830 ()


  • Surgical torque wrench adaptor

Blue Sky Bio, LLC. - 00810060224687

Bio | Cut Guide Tube 5.8 OD x 4.8 ID x 4mm L
BLUE SKY BIO LLC
TUBE58-48-4L
In Commercial Distribution

  • 00810060224687 ()


  • Surgical torque wrench adaptor

Blue Sky Bio, LLC - 00810060224151

BIO | Guide-Tube 7.2 OD x 6.26 ID x 3.5mm L
BLUE SKY BIO LLC
TUBE73-63-6L
In Commercial Distribution

  • 00810060224151 ()


  • Surgical torque wrench adaptor
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