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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10mm wrench
Paragon 28, Inc.
P47-950-0001
In Commercial Distribution

  • 00889795114921 ()
P47-950-0001

  • Surgical instrument handle, non-torque-limiting
T-wrench/pin driver
Paragon 28, Inc.
P47-940-0001
In Commercial Distribution

  • 00889795114914 ()
P47-940-0001

  • Surgical instrument handle, non-torque-limiting
Trocar for Tissue Protector
Paragon 28, Inc.
P47-930-0001
In Commercial Distribution

  • 00889795114907 ()
P47-930-0001

  • Orthopaedic implantation sleeve, reusable
Tissue Protector Sleeve
Paragon 28, Inc.
P47-920-0001
In Commercial Distribution

  • 00889795114891 ()
P47-920-0001

  • Orthopaedic implantation sleeve, reusable
Tissue Protector w/Handle
Paragon 28, Inc.
P47-910-0001
In Commercial Distribution

  • 00889795114884 ()
P47-910-0001

  • Orthopaedic implantation sleeve, reusable
Sterilization Case
Paragon 28, Inc.
P47-900-0001
In Commercial Distribution

  • 00889795114877 ()
P47-900-0001

  • Device sterilization/disinfection container, reusable
4.0mm x 200mm Calibrated Step Drill
Paragon 28, Inc.
P47-100-4020
In Commercial Distribution

  • 00889795114860 ()
P47-100-4020

  • Cannulated surgical drill bit, reusable
3.2mm x 165mm Calibrated Step Drill
Paragon 28, Inc.
P47-100-3216
In Commercial Distribution

  • 00889795114853 ()
P47-100-3216

  • Cannulated surgical drill bit, reusable
2.4mm x 140mm Calibrated Step Drill
Paragon 28, Inc.
P47-100-2414
In Commercial Distribution

  • 00889795114846 ()
P47-100-2414

  • Cannulated surgical drill bit, reusable
30 Degree angled post
Paragon 28, Inc.
P47-510-P030
In Commercial Distribution

  • 00889795114839 ()
P47-510-P030

  • External orthopaedic fixation system, single-use
Straight Post
Paragon 28, Inc.
P47-510-P000
In Commercial Distribution

  • 00889795114822 ()
P47-510-P000

  • External orthopaedic fixation system, single-use
11mm x 500mm Carbon Bar
Paragon 28, Inc.
P47-410-0500
In Commercial Distribution

  • 00889795114815 ()
P47-410-0500

  • External orthopaedic fixation system, single-use
11mm x 450mm Carbon Bar
Paragon 28, Inc.
P47-410-0450
In Commercial Distribution

  • 00889795114808 ()
P47-410-0450

  • External orthopaedic fixation system, single-use
11mm x 400mm Carbon Bar
Paragon 28, Inc.
P47-410-0400
In Commercial Distribution

  • 00889795114792 ()
P47-410-0400

  • External orthopaedic fixation system, single-use
11mm x 350mm Carbon Bar
Paragon 28, Inc.
P47-410-0350
In Commercial Distribution

  • 00889795114785 ()
P47-410-0350

  • External orthopaedic fixation system, single-use
11mm x 300mm Carbon Bar
Paragon 28, Inc.
P47-410-0300
In Commercial Distribution

  • 00889795114778 ()
P47-410-0300

  • External orthopaedic fixation system, single-use
11mm x 250mm Carbon Bar
Paragon 28, Inc.
P47-410-0250
In Commercial Distribution

  • 00889795114761 ()
P47-410-0250

  • External orthopaedic fixation system, single-use
11mm x 200mm Carbon Bar
Paragon 28, Inc.
P47-410-0200
In Commercial Distribution

  • 00889795114754 ()
P47-410-0200

  • External orthopaedic fixation system, single-use
11mm x 150mm Carbon Bar
Paragon 28, Inc.
P47-410-0150
In Commercial Distribution

  • 00889795114747 ()
P47-410-0150

  • External orthopaedic fixation system, single-use
8 hole pin clamp
Paragon 28, Inc.
P47-320-0008
In Commercial Distribution

  • 00889795114730 ()
P47-320-0008

  • External orthopaedic fixation system, single-use
5 hole pin clamp
Paragon 28, Inc.
P47-320-0005
In Commercial Distribution

  • 00889795114723 ()
P47-320-0005

  • External orthopaedic fixation system, single-use
11mm bar to 11mm bar/5mm pin
Paragon 28, Inc.
P47-310-1105
In Commercial Distribution

  • 00889795114716 ()
P47-310-1105

  • External orthopaedic fixation system, single-use
5mm Pin Cap (10 Pack)
Paragon 28, Inc.
P47-230-0525
In Commercial Distribution

  • 00889795114709 ()
P47-230-0525

  • Pin-sleeve orthopaedic bone screw
5mm x 325mm Transfixation Pin, Centrally Threaded
Paragon 28, Inc.
P47-220-5325
In Commercial Distribution

  • 00889795114693 ()
P47-220-5325

  • External orthopaedic fixation system, single-use
5mm x 65mm Half Pin, 200mm length (Blunt Tipped)
Paragon 28, Inc.
P47-210-565B
In Commercial Distribution

  • 00889795114686 ()
P47-210-565B

  • External orthopaedic fixation system, single-use
5mm x 65mm Half Pin, 200mm length (Self Tapping)
Paragon 28, Inc.
P47-210-565S
In Commercial Distribution

  • 00889795114679 ()
P47-210-565S

  • External orthopaedic fixation system, single-use
5mm x 55mm Half Pin, 200mm length (Blunt Tipped)
Paragon 28, Inc.
P47-210-555B
In Commercial Distribution

  • 00889795114662 ()
P47-210-555B

  • External orthopaedic fixation system, single-use
5mm x 55mm Half Pin, 200mm length (Self Tapping)
Paragon 28, Inc.
P47-210-555S
In Commercial Distribution

  • 00889795114655 ()
P47-210-555S

  • External orthopaedic fixation system, single-use
5mm x 45mm Half Pin, 150mm length (Blunt Tipped)
Paragon 28, Inc.
P47-210-545B
In Commercial Distribution

  • 00889795114648 ()
P47-210-545B

  • External orthopaedic fixation system, single-use
5mm x 45mm Half Pin, 150mm length (Self Tapping)
Paragon 28, Inc.
P47-210-545S
In Commercial Distribution

  • 00889795114631 ()
P47-210-545S

  • External orthopaedic fixation system, single-use
5mm x 35mm Half Pin, 150mm length (Blunt Tipped)
Paragon 28, Inc.
P47-210-535B
In Commercial Distribution

  • 00889795114624 ()
P47-210-535B

  • External orthopaedic fixation system, single-use
5mm x 35mm Half Pin, 150mm length (Self Tapping)
Paragon 28, Inc.
P47-210-535S
In Commercial Distribution

  • 00889795114617 ()
P47-210-535S

  • External orthopaedic fixation system, single-use
4mm x 30mm Half Pin (Blunt Tipped)
Paragon 28, Inc.
P47-210-430B
In Commercial Distribution

  • 00889795114600 ()
P47-210-430B

  • External orthopaedic fixation system, single-use
4mm x 30mm Half Pin (Self Tapping)
Paragon 28, Inc.
P47-210-430S
In Commercial Distribution

  • 00889795114594 ()
P47-210-430S

  • External orthopaedic fixation system, single-use
4mm x 20mm Half Pin (Blunt Tipped)
Paragon 28, Inc.
P47-210-420B
In Commercial Distribution

  • 00889795114587 ()
P47-210-420B

  • External orthopaedic fixation system, single-use
4mm x 20mm Half Pin (Self Tapping)
Paragon 28, Inc.
P47-210-420S
In Commercial Distribution

  • 00889795114570 ()
P47-210-420S

  • External orthopaedic fixation system, single-use
3mm x 20mm Half Pin (Blunt Tipped)
Paragon 28, Inc.
P47-210-320B
In Commercial Distribution

  • 00889795114563 ()
P47-210-320B

  • External orthopaedic fixation system, single-use
3mm x 20mm Half Pin (Self Tapping)
Paragon 28, Inc.
P47-210-320S
In Commercial Distribution

  • 00889795114556 ()
P47-210-320S

  • External orthopaedic fixation system, single-use
STERILE-Male Implant
Paragon 28, Inc.
P42-222-0075-S
In Commercial Distribution

  • 00889795114549 ()
P42-222-0075-S

  • Tendon/ligament bone anchor, non-bioabsorbable
STERILE-Female Implant, Long
Paragon 28, Inc.
P42-322-0095-S
In Commercial Distribution

  • 00889795114532 ()
P42-322-0095-S

  • Tendon/ligament bone anchor, non-bioabsorbable
STERILE-Female Implant, Short
Paragon 28, Inc.
P42-322-0065-S
In Commercial Distribution

  • 00889795114525 ()
P42-322-0065-S

  • Tendon/ligament bone anchor, non-bioabsorbable
TenoTac Sterile Kit System, Ø8mm x 2.2mm x 7.5mm
Paragon 28, Inc.
P42-222-0075-SK
In Commercial Distribution

  • 00889795114518 ()
P42-222-0075-SK

  • Tendon/ligament bone anchor, non-bioabsorbable
R3ACT Stablization System Implant, Ø4.2 X 50mm, 15.5mm Notch, Ti-6Al-4V ELI, Sterile
Paragon 28, Inc.
P80-142-1550-S
In Commercial Distribution

  • 00889795114433 ()
P80-142-1550-S

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
R3ACT Stablization System Implant, Ø4.2 X 70mm, 14mm Notch, Ti-6Al-4V ELI, Sterile
Paragon 28, Inc.
P80-142-1470-S
In Commercial Distribution

  • 00889795114402 ()
P80-142-1470-S

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
R3ACT Stablization System Implant, Ø4.2 X 65mm, 14mm Notch, Ti-6Al-4V ELI, Sterile
Paragon 28, Inc.
P80-142-1465-S
In Commercial Distribution

  • 00889795114396 ()
P80-142-1465-S

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
Cannulated Drill, ø4.5mm x 10cm, Sterile
Paragon 28, Inc.
P44-941-4310-S
In Commercial Distribution

  • 00889795114372 ()
P44-941-4310-S

  • Cannulated surgical drill bit, single-use
Cannulated Drill, ø3.5mm x 10cm, Sterile
Paragon 28, Inc.
P44-941-3510-S
In Commercial Distribution

  • 00889795114365 ()
P44-941-3510-S

  • Cannulated surgical drill bit, single-use
Cannulated Tap, Ø5.5mm x 10cm, Sterile
Paragon 28, Inc.
P44-960-0055-S
In Commercial Distribution

  • 00889795114358 ()
P44-960-0055-S

  • Bone tap, single-use
Cannulated Tap, Ø4.5mm x 10cm, Sterile
Paragon 28, Inc.
P44-960-0045-S
In Commercial Distribution

  • 00889795114341 ()
P44-960-0045-S

  • Bone tap, single-use
BridgeLine Suture Tape, 4mm, UHMWPE/PGLA, Sterile
Paragon 28, Inc.
P44-310-0004-S
In Commercial Distribution

  • 00889795114334 ()
P44-310-0004-S

  • Suturing unit, single-use
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