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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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Grappler PEEK Interference Screw 4 x 15mm
Paragon 28, Inc.
P41-040-1500-S
In Commercial Distribution

  • 00889795053695 ()
P41-040-1500-S

  • Tendon/ligament bone anchor, non-bioabsorbable
Grappler PEEK Interference Screw 4 x 10mm
Paragon 28, Inc.
P41-040-1000-S
In Commercial Distribution

  • 00889795053688 ()
P41-040-1000-S

  • Tendon/ligament bone anchor, non-bioabsorbable
K-Wire, Single Ended Trocar Tip, SMOOTH, 0.9 x 100mm
Paragon 28, Inc.
P99-192-0910
In Commercial Distribution

  • 00889795053671 ()
P99-192-0910

  • Orthopaedic bone wire
TenoTac Female Implant Depth Gauge
Paragon 28, Inc.
P42-951-0001
In Commercial Distribution

  • 00889795053640 ()
P42-951-0001

  • Tendon/ligament bone anchor, non-bioabsorbable
TenoTac Female Implant Driver, T15
Paragon 28, Inc.
P42-902-T151
In Commercial Distribution

  • 00889795053633 ()
P42-902-T151

  • Tendon/ligament bone anchor, non-bioabsorbable
TenoTac Male Implant Inserter, T15
Paragon 28, Inc.
P42-901-T154
In Commercial Distribution

  • 00889795053626 ()
P42-901-T154

  • Tendon/ligament bone anchor, non-bioabsorbable
TenoTac ø2.8mm Cannulated Drill, ø6.0mm Countersink, 20mm Long
Paragon 28, Inc.
P42-917-2820
In Commercial Distribution

  • 00889795053619 ()
P42-917-2820

  • Cannulated surgical drill bit, reusable
TenoTac Female, LONG 4.5 x 2.2 x 10mm
Paragon 28, Inc.
P42-122-0100
In Commercial Distribution

  • 00889795053602 ()
P42-122-0100

  • Tendon/ligament bone anchor, non-bioabsorbable
TenoTac Female, MED 4.5 x 2.2 x 7.5mm
Paragon 28, Inc.
P42-122-0075
In Commercial Distribution

  • 00889795053596 ()
P42-122-0075

  • Tendon/ligament bone anchor, non-bioabsorbable
TenoTac Female, SHORT, 4.5 x 2.2 x 5mm
Paragon 28, Inc.
P42-122-0050
In Commercial Distribution

  • 00889795053589 ()
P42-122-0050

  • Tendon/ligament bone anchor, non-bioabsorbable
TenoTac Male, 6 x 2.2 x 6.5mm
Paragon 28, Inc.
P42-022-0065
In Commercial Distribution

  • 00889795053572 ()
P42-022-0065

  • Tendon/ligament bone anchor, non-bioabsorbable
TenoTac Caddy Lid
Paragon 28, Inc.
P42-900-LID
In Commercial Distribution

  • 00889795053565 ()
P42-900-LID

  • Device sterilization/disinfection container, reusable
TenoTac Caddy Base
Paragon 28, Inc.
P42-900-BASE
In Commercial Distribution

  • 00889795053558 ()
P42-900-BASE

  • Device sterilization/disinfection container, reusable
PROMO Cut Guide V3
Paragon 28, Inc.
P51-908-0012
In Commercial Distribution

  • 00889795053510 ()
P51-908-0012

  • Osteotomy guide, reusable
PROMO, Precision Guide, V1.5
Paragon 28, Inc.
P51-908-0010
In Commercial Distribution

  • 00889795053503 ()
P51-908-0010

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Monster, Countersink, 7.0mm, Bowl Washer
Paragon 28, Inc.
P20-910-WB70
In Commercial Distribution

  • 00889795053497 ()
P20-910-WB70

  • Surgical countersink, reusable
Half Olive Wire, Large Olive (7mm), ø1.60mm x 9cm, Threaded
Paragon 28, Inc.
P99-205-1609
In Commercial Distribution

  • 00889795053480 ()
P99-205-1609

  • Orthopaedic bone wire
Half Olive Wire, Large Olive (7mm), ø1.60mm x 8cm, Threaded
Paragon 28, Inc.
P99-205-1608
In Commercial Distribution

  • 00889795053473 ()
P99-205-1608

  • Orthopaedic bone wire
Half Olive Wire, Large Olive (7mm), ø1.60mm x 9cm, Smooth
Paragon 28, Inc.
P99-204-1609
In Commercial Distribution

  • 00889795053466 ()
P99-204-1609

  • Orthopaedic bone wire
Half Olive Wire, Large Olive (7mm), ø1.60mm x 8cm, Smooth
Paragon 28, Inc.
P99-204-1608
In Commercial Distribution

  • 00889795053459 ()
P99-204-1608

  • Orthopaedic bone wire
K-Wire, Single Ended Trocar Tip, Threaded, 2.0 x 200mm
Paragon 28, Inc.
P99-193-2020
In Commercial Distribution

  • 00889795053442 ()
P99-193-2020

  • Orthopaedic bone wire
2.0MM X 20CM K-Wire
Paragon 28, Inc.
P99-192-2020
In Commercial Distribution

  • 00889795053435 ()
P99-192-2020

  • Orthopaedic bone wire
Over Drill, 5.2 x 120mm, Solid, AO
Paragon 28, Inc.
P99-100-5212
In Commercial Distribution

  • 00889795053374 ()
P99-100-5212

  • Fluted surgical drill bit, reusable
Over Drill, 4.5 x 120mm, Solid, AO
Paragon 28, Inc.
P99-100-4512
In Commercial Distribution

  • 00889795053367 ()
P99-100-4512

  • Fluted surgical drill bit, reusable
Drill, 3.6 x 160mm, Solid, Measuring, Long, AO
Paragon 28, Inc.
P99-100-3616
In Commercial Distribution

  • 00889795053350 ()
P99-100-3616

  • Fluted surgical drill bit, reusable
Drill, 3.1 x 160mm, Solid, Measuring, Long, AO
Paragon 28, Inc.
P99-100-3116
In Commercial Distribution

  • 00889795053343 ()
P99-100-3116

  • Fluted surgical drill bit, reusable
Drill, 2.8 x 160mm, Solid, Measuring, Long, AO
Paragon 28, Inc.
P99-100-2816
In Commercial Distribution

  • 00889795053336 ()
P99-100-2816

  • Fluted surgical drill bit, reusable
Drill, 2.4 x 160mm, Solid, Measuring, Long, AO
Paragon 28, Inc.
P99-100-2416
In Commercial Distribution

  • 00889795053329 ()
P99-100-2416

  • Fluted surgical drill bit, reusable
Bone Fenestration Perforator
Paragon 28, Inc.
P99-100-2010
In Commercial Distribution

  • 00889795053312 ()
P99-100-2010

  • Fluted surgical drill bit, reusable
Posterior TTC Plate, Long, Right
Paragon 28, Inc.
P53-403-R102
In Commercial Distribution

  • 00889795053305 ()
P53-403-R102

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
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