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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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Drill, 7.0 X 130mm, Cannulated, 3/16" Sq. Connection w/ Depth Mark
Paragon 28, Inc.
P41-910-7013
In Commercial Distribution

  • 00889795057358 ()
P41-910-7013

  • Cannulated surgical drill bit, reusable
Drill, 6.5 X 130mm, Cannulated, 3/16" Sq. Connection w/ Depth Mark
Paragon 28, Inc.
P41-910-6513
In Commercial Distribution

  • 00889795057341 ()
P41-910-6513

  • Cannulated surgical drill bit, reusable
Drill, 6.0 X 130mm, Cannulated, 3/16" Sq. Connection w/ Depth Mark
Paragon 28, Inc.
P41-910-6013
In Commercial Distribution

  • 00889795057334 ()
P41-910-6013

  • Cannulated surgical drill bit, reusable
Drill, 5.5 X 130mm, Cannulated, 3/16" Sq. Connection w/ Depth Mark
Paragon 28, Inc.
P41-910-5513
In Commercial Distribution

  • 00889795057327 ()
P41-910-5513

  • Cannulated surgical drill bit, reusable
Drill, 5.0 X 130mm, Cannulated, 3/16" Sq. Connection w/ Depth Mark
Paragon 28, Inc.
P41-910-5013
In Commercial Distribution

  • 00889795057310 ()
P41-910-5013

  • Cannulated surgical drill bit, reusable
Drill, 4.5 X 130mm, Cannulated, 3/16" Sq. Connection w/ Depth Mark
Paragon 28, Inc.
P41-910-4513
In Commercial Distribution

  • 00889795057303 ()
P41-910-4513

  • Cannulated surgical drill bit, reusable
Drill, 4.0 X 130mm, Cannulated, 3/16" Sq. Connection w/ Depth Mark
Paragon 28, Inc.
P41-910-4013
In Commercial Distribution

  • 00889795057297 ()
P41-910-4013

  • Cannulated surgical drill bit, reusable
(Extra Long) TenoTac Female Implant ø4.5mm x 2.2mm x 12.5mm Long
Paragon 28, Inc.
P42-122-0125
In Commercial Distribution

  • 00889795057280 ()
P42-122-0125

  • Tendon/ligament bone anchor, non-bioabsorbable
TenoTac Male Implant ø8mm x 2.2mm x 10mm Long
Paragon 28, Inc.
P42-822-0100
In Commercial Distribution

  • 00889795057273 ()
P42-822-0100

  • Tendon/ligament bone anchor, non-bioabsorbable
TenoTac Single Use ø2.8mm Cannulated Drill, ø8.0mm Countersink, 25mm Long
Paragon 28, Inc.
P42-938-2825
In Commercial Distribution

  • 00889795057266 ()
P42-938-2825

  • Surgical countersink, reusable
TenoTac Single Use ø2.8mm Cannulated Drill, ø6.0mm Countersink, 20mm Long
Paragon 28, Inc.
P42-937-2820
In Commercial Distribution

  • 00889795057259 ()
P42-937-2820

  • Surgical countersink, reusable
TenoTac Single Use Female Implant Length Gauge 1st
Paragon 28, Inc.
P42-935-0002
In Commercial Distribution

  • 00889795057242 ()
P42-935-0002

  • Surgical depth gauge, reusable
TenoTac Single Use Female Implant Length Gauge 2nd, 3rd, 4th
Paragon 28, Inc.
P42-935-0001
In Commercial Distribution

  • 00889795057235 ()
P42-935-0001

  • Surgical depth gauge, reusable
TenoTac Single Use Female Implant Driver, T15
Paragon 28, Inc.
P42-932-T151
In Commercial Distribution

  • 00889795057228 ()
P42-932-T151

  • Tendon/ligament bone anchor, non-bioabsorbable
TenoTac Single Use Male Implant Inserter T15 Driver, 40mm Inserter Wire
Paragon 28, Inc.
P42-931-T154
In Commercial Distribution

  • 00889795057211 ()
P42-931-T154

  • Tendon/ligament bone anchor, non-bioabsorbable
(Extra Long) TenoTac Female Implant ø4.5mm x 2.2mm x 12.5mm Long Sterile Packaged
Paragon 28, Inc.
P42-122-0125-S
In Commercial Distribution

  • 00889795057204 ()
P42-122-0125-S

  • Tendon/ligament bone anchor, non-bioabsorbable
(Long) TenoTac Female Implant ø4.5mm x 2.2mm x 10mm Long Sterile Packaged
Paragon 28, Inc.
P42-122-0100-S
In Commercial Distribution

  • 00889795057198 ()
P42-122-0100-S

  • Tendon/ligament bone anchor, non-bioabsorbable
(Medium) TenoTac Female Implant ø4.5mm x 2.2mm x 7.5mm Long Sterile Packaged
Paragon 28, Inc.
P42-122-0075-S
In Commercial Distribution

  • 00889795057181 ()
P42-122-0075-S

  • Tendon/ligament bone anchor, non-bioabsorbable
(Short) TenoTac Female Implant ø4.5mm x 2.2mm x 5mm Long Sterile Packaged
Paragon 28, Inc.
P42-122-0050-S
In Commercial Distribution

  • 00889795057174 ()
P42-122-0050-S

  • Tendon/ligament bone anchor, non-bioabsorbable
TenoTac Male Implant ø8mm x 2.2mm x 10mm Long Sterile Packaged
Paragon 28, Inc.
P42-822-0100-S
In Commercial Distribution

  • 00889795057167 ()
P42-822-0100-S

  • Tendon/ligament bone anchor, non-bioabsorbable
TenoTac Male Implant ø6mm x 2.2mm x 6.5mm Long Sterile Packaged
Paragon 28, Inc.
P42-022-0065-S
In Commercial Distribution

  • 00889795057150 ()
P42-022-0065-S

  • Tendon/ligament bone anchor, non-bioabsorbable
TenoTac Sterile Kit 1st Digit BOM (diameter 8.0mm male x 10.0mm long)
Paragon 28, Inc.
P42-822-0100-SK
In Commercial Distribution

  • 00889795057143 ()
P42-822-0100-SK

  • Tendon/ligament bone anchor, non-bioabsorbable
TenoTac Sterile Kit 2nd, 3rd, 4th Digit BOM (diameter 6.0mm male x 6.5mm long)
Paragon 28, Inc.
P42-022-0065-SK
In Commercial Distribution

  • 00889795057136 ()
P42-022-0065-SK

  • Tendon/ligament bone anchor, non-bioabsorbable
14 x 7 Subtalar Trial
Paragon 28, Inc.
PST-1407
In Commercial Distribution

  • 00889795057129 ()
PST-1407

  • Surgical implant template, reusable
16 x 8 Subtalar Trial
Paragon 28, Inc.
PST-1608
In Commercial Distribution

  • 00889795057112 ()
PST-1608

  • Surgical implant template, reusable
10 x 5 Subtalar Trial
Paragon 28, Inc.
PST-1005
In Commercial Distribution

  • 00889795057105 ()
PST-1005

  • Surgical implant template, reusable
16mm Calc-Cuboid Trial Assembly
Paragon 28, Inc.
PCC-016
In Commercial Distribution

  • 00889795057099 ()
PCC-016

  • Surgical implant template, reusable
14mm Calc-Cuboid Trial Assembly
Paragon 28, Inc.
PCC-014
In Commercial Distribution

  • 00889795057082 ()
PCC-014

  • Surgical implant template, reusable
8mm Calc-Cuboid Trial Assembly
Paragon 28, Inc.
PCC-008
In Commercial Distribution

  • 00889795057075 ()
PCC-008

  • Surgical implant template, reusable
Subtalar Handle
Paragon 28, Inc.
PST-0001
In Commercial Distribution

  • 00889795057068 ()
PST-0001

  • Surgical implant template, reusable
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